Gastrointestinal Cancer Clinical Trials

19 trials identified.

Negative Pressure Wound Therapy for Abdominal Surgeries
Principal Investigator: Blazer, Dan
Protocol Number: PRO00045975

Age Group: Adult
Scope: National

Phase: II
Disease Site: Anus; Colon; Kidney; Liver; Other Digestive Organ; Pancreas; Rectum; Unknown Sites

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Wound care for abdominal (colorectal, liver, or pancreas) surgery
What is the Purpose of this Study?
We are doing this study to learn whether negative pressure wound therapy (NPWT) helps to lower the rate of surgical site infections (SSI) in patients having abdominal surgery compared to routine post-operative wound care. 
Who Can Participate in the Study?
Adult men and women who:
- Are scheduled for an elective open colorectal or hepatopancreatobiliary (liver or pancreas) surgery. 

You may not join the study if you are having emergency or laparoscopic surgery
What is Involved?
If you choose to join this study, you will:
- Be randomized (like a flip of a coin) to one of two groups. 

--- Group One will get a standard wound dressing over their surgical incision. 
--- Group Two will have a negative pressure wound therapy (either Prevena Incision Management System or ActiVAC) that will be put on their surgical incision. 

- We will monitor you for post-operative infection the day of your surgery, 4-5 days after surgery and again between 15 and 45 days after your surgery. 

You will not need to have any additional clinic visits outside of your standard postoperative care. 

Your records will also be monitored for any side effects of your dressing or device.
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

DKK1 for Gastric Cancer
Principal Investigator: Strickler, John
Protocol Number: PRO00049984

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Esophagus; Other Digestive Organ

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Gastric cancer
What is the Purpose of this Study?
We are doing this study to see if the study drug (DKN-01) is safe by itself and if the study drug may be taken with paclitaxel or pembrolizumab. 
Who Can Participate in the Study?
Adults who:
- Have histologically confirmed recurrent or metastatic esophageal or GEJ squamous cell or adenocarcinoma 
What is Involved?
If you choose to join this study you will:
- Be put into Parts A-F or monotherapy of this study
-- For parts A-E, you will be given DKN-01 through your vein on Day 1 and Day 15, and paclitaxel on Day 1, 8, 15 and 22 of each 28 day cycle 
-- If you are put in Arm F, you will be given DKN-01 through your vein on Day 1, and 15, and pembrolizumab on Day 1 of each 21 day cycle
-- If you are put in the monotherapy sub-study, you will only get DKN-01 on Day 1 and 15 of each 28 Day cycle
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

S1316 - Malignant Bowel Obstruction
Principal Investigator: Secord, Angeles
Protocol Number: PRO00058895

Age Group: Adult
Scope: National

Phase: III
Disease Site: Cervix; Other Female Genital; Ovary; Pancreas

Contact: DCI Clinical Research Team, GYN Oncology
Email:

What is the Condition Being Studied?
Malignant bowel obstruction
What is the Purpose of this Study?
We are doing this study to compare the quality of life for participants with malignant bowel obstruction who are treated with surgery to that of similar participants who are treated with the best medical management (non-surgical treatment).
Who Can Participate in the Study?
Adults with malignant bowel obstruction.
What is Involved?
If you agree to be in the study you will:
Be randomized (like a flip of a coin) to one of two standard malignant bowel treatments.
-- Group 1 participants will receive the usual abdominal surgery for malignant bowel obstruction.
-- Group 2 participants will receive the usual non-surgical treatment for malignant bowel obstruction.

Weekly telephone call (or hospital visits if you are in the hospital) for 13 weeks from the start of the study and then monthly telephone calls for up to 1 year. Each telephone call or hospital visit will last for about 15 minutes.

Monthly telephone calls from the Arizona Diet, Behavior, and Quality of Life Assessment Lab to find out what you are eating. Each telephone call will last for about 15-20 minutes.
Participating Institutions:
  • Duke University Health System : GYN Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1: Nivo and Anal Cancer
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00064189

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Anus

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Advanced anal canal cancer 
What is the Purpose of this Study?
We are doing this study to learn about any good and bad effects of nivolumab in combination with ipilimumab and to learn if biomarker tests are helpful to decide if people will benefit from these treatments. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drugs.
Who Can Participate in the Study?
-- Adult patients with confirmed previously treated metastatic squamous cell carcinoma of the anal canal
-- Willing to undergo testing for HIV testing if not tested within the past 6 months.
What is Involved?
If you join the study you will be enrolled in Part B
-- You will be put into a group by chance (like flipping a coin).  Your doctor will not choose and you cannot choose which study group you are in. You will have an equal chance of being in either group. 
-- You will receive either Nivolumab OR Nivolumab plus Ipilimumab. 
-- Nivolumab will be given intravenously through your vein over 30 minutes once every 4 weeks.
--- If you are assigned to Ipilimumab group, it will be given intravenously through your vein over 30 minutes once every 8 weeks. 

You will receive nivolumab alone or nivolumab with ipilimumab for as long as you receive clinical benefit. 

After you finish treatment, the study team will continue to watch you for side effects for at least 100 days. 
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

MedImmune HCC D4190C00022 for Liver Cancer
Principal Investigator: Morse, Michael
Protocol Number: PRO00066636

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Liver; Other Digestive Organ

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Hepatocellular carcinoma
What is the Purpose of this Study?
We are doing this study to learn whether the study drugs Durvalumab and Tremelimumab are safe for patients, and whether the study drug regimen can reduce or slow the growth of your cancer. 

Additionally, we want to learn what effects, good or bad, the study drugs may have on your body. 
Who Can Participate in the Study?
Adults who:
- Have never had treatment with drugs similar to durvalumab, tremelimumab, or bevacizumab 
- Have a body weight of at least 66 pounds
- Have hepatocellular carcinoma
What is Involved?
If you choose to join this study, you will:
- Be randomly assigned (like drawing numbers out of a hat) to one of following 3 study regimens by random chance:
-- Durvalumab given alone at a dose of 1500 mg every 4 weeks.
-- Tremelimumab given alone at a dose of 750 mg every 4 weeks 7 times then every 12 weeks 
-- A combination of durvalumab at a dose of 1500 mg and tremelimumab at a dose of 300 mg together 1 time followed by durvalumab alone at a dose of 1500 mg given every 4 weeks
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Niclosamide for Colon Cancer
Principal Investigator: Morse, Michael
Protocol Number: PRO00066964

Age Group: Adult
Scope: Local

Phase: I (Cancer Control)
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Colon Cancer
What is the Purpose of this Study?
We are doing this study to find out what effects (good and bad) that the study drug, niclosamide, has on you and your cancer.  

We are trying to learn if giving niclosamide to people with cancer is safe and if it affects your cancer.  
Who Can Participate in the Study?
Adults who:
- Have color cancer
- Have brain metastases
- Not have an active infection including HIV or hepatitis 
What is Involved?
If you choose to join this study, you will: 
- Be taking the study drug,niclosamide, by mouth every day for 7 days before your surgery. 
- The dose of study drug and how often (either once per day or twice per day) you take it will depend on when you start the study.  
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Macrogenics: Margetuximab for HER2 Gastric Cancer
Principal Investigator: Uronis, Hope
Protocol Number: PRO00068590

Age Group: Adult
Scope: National

Phase: I/II (Cancer Control)
Disease Site: Esophagus; Stomach

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Gastric Cancer
What is the Purpose of this Study?
We are doing this study to learn if the study drugs are safe for patients, if they can reduce or slow the growth of your cancer, and what effects, good or bad, these drugs may have on your body. 
Who Can Participate in the Study?
Adults who: 
- Have unresectable HER2 positive gastric cancer
What is Involved?
If you choose to join this study, you will:
- Receive both margetuximab and pembrolizumab given once every 3 weeks 
-- Both pembrolizumab and margetuximab will be given by injection into your vein in the clinic at Duke 
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

PLANET: Pemcrolizumab and Lanreotide for Gastroenteropancreatic Neuroendocrine Tumors
Principal Investigator: Morse, Michael
Protocol Number: PRO00074917

Age Group: Adult
Scope: Local

Phase: I/II (Cancer Control)
Disease Site: Other Digestive Organ

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Neuroendocrine tumor of the gastrointestinal (GI) tract or pancreas (GEP-NET)
What is the Purpose of this Study?
We are doing this study to learn if the study drug combination of pembrolizumab and lanreotide is safe for patients and also if these drugs can slow, stop, or make your tumor smaller. 
Who Can Participate in the Study?
Adults who:
- Have gastroenteropancreatic neuroendocrine tumor (GEP-NETs)
- Do not have an active infection requiring systemic therapy
What is Involved?
If you choose to join this study, you will:
- Get Pembrolizumab by injection into your vein every 3 weeks and Lanreotide by injection under your skin every 3 weeks
-- These 21-day cycles will be repeated until your cancer gets worse or you are no longer able to tolerate the study drugs
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Alliance A021501 (Pancreatic Cancer)
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00078527

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Pancreas

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Pancreatic Cancer
What is the Purpose of this Study?
We are doing this study to compare any good and bad effects of using chemotherapy compared to chemotherapy with radiation before surgery. This study will show us which approach is better, the same, or worse than the other. 
Who Can Participate in the Study?
Adults with pancreatic cancer who:
- Have not had chemotherapy or radiation therapy for pancreatic cancer
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Get 8 cycles (1 cycle is equal to 14 days) of chemotherapy before surgery
- Have a scan to see if removing your cancer is appropriate
- Get 4 more cycles of chemotherapy if you have surgery.  The cycles will be after your surgery
- Answer questionnaires to see how you are feeling physically and emotionally during your cancer treatment
- Be followed with clinic visits, scans and blood tests for about 5 years from the day you started the surgery after the chemotherapy and surgery are done
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

KeyLARGO
Principal Investigator: Uronis, Hope
Protocol Number: PRO00080566

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Esophagus; Stomach

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Esophageal/ Stomach Cancer
What is the Purpose of this Study?
We are doing this study learn about the good and bad side effects pembrolizumab, oxaliplatin, and capecitabine has on you and your cancer. 
Who Can Participate in the Study?
Adults who:
- Are diagnosed with recurrent (metastatic) cancer (adenocarcinoma) of the esophagus or stomach 
- Are HER2 Negative unless you cannot take Herceptin
- Have not had any prior treatment for their cancer, with a few exceptions
What is Involved?
The study will be done in two stages: 

Stage 1 is a safety study to make sure the study drug is safe and doesn't cause too many bad side effects.

Stage 2 is a dose expansion study where the study drug will be given to a higher number of subjects to make sure the study drug is safe and doesn't cause too many bad side effects.

If you choose to join this study, you will:
- Get pembrolizumab and oxaliplatin into a vein on day 1 of each 21 days and Capecitabine by mouth on days 1-14 of each 21 day cycle. 
- Have routine clinic visits to check you and your cancer
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Gastrointestinal Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Gastrointestinal Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Gastrointestinal Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

MOUNTAINEER: Tucatinib for HER2+ Colorectal Cancer
Principal Investigator: Strickler, John
Protocol Number: PRO00082879

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Metastatic Colorectal Cancer
What is the Purpose of this Study?
We are doing this study to look at the effects (good and/or bad) of taking study drugs Tucatinib and Trastuzumab has on you and your metastatic colorectal cancer. 
Who Can Participate in the Study?
Adults who:
- Are diagnosed with metastatic colorectal cancer
- Have a positive test for HER2 overexpression or amplification
- Have not been treated with anti-HER2 therapy
What is Involved?
If you choose to join this study, you will: 
- Get the study drugs tucatinib and trastuzumab 
-- Tucatinib is given by mouth twice a day and trastuzumab is given into your arm the first day of every 21 days in the clinic at Duke
-- This cycle will be repeated until your cancer gets worse or you have bad side effects or you choose to stop the study for any reason. 
- Have tests, exams and procedures that are part of your standard of care and for study purposes. Clinic visits will usually last 4-5 hours
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 9947 Cisplatin/Gemcitabine +/- VX-970 in Metastatic Urothelial Carcinoma
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00083963

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Urinary Bladder

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Bladder cancer that has spread beyond the bladder
What is the Purpose of this Study?
We are doing this study to compare any good and bad effects of using VX-970 along with the usual chemotherapy compared to usual chemotherapy alone. 
Who Can Participate in the Study?
Adult patients with bladder cancer that has spread beyond the bladder who are planning to receive standard chemotherapy (cisplatin with gemcitabine).  
What is Involved?
If you join this study, after a screening period, you will be randomized (like the flip of a coin) to one of 2 groups: 
-- standard chemotherapy (cisplatin with gemcitabine) alone
OR
-- standard chemo therapy plus VX-970.  
-- You will receive treatment in 3 week cycles for up to 6 cycles.  
-- You will have regular clinic visits and labs to see how you are tolerating the treatment.  
-- You will also have imaging every 9 weeks to see whether your cancer is responding to the treatment.  
Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10021 Durvalumab & Tremelimumab +/- Radiation in mCRC & NSCLC
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00085875

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Ill-Defined Sites

Contact: DCI Clinical Research Team, Phase I Clinical Trials Office
Email:

What is the Condition Being Studied?
Advanced non-small cell lung cancer 
What is the Purpose of this Study?
We are doing this study to test any good and bad effects of the experimental study drugs, MEDI4736 (durvalumab) and tremelimumab given alone or in combination with either low or higher doses of radiation.
Who Can Participate in the Study?
Adults with advanced non-small cell lung cancer that has progressed after receiving prior treatment(s)
What is Involved?
If you join this study, you will receive one of the three treatment options.  The study group you will belong to will be decided by chance (like tossing a coin) because no one knows if one study group is better than the other

Group 1 will receive MEDI4736 (durvalumab) & tremelimumab only

Group 2 will receive MEDI4736 (durvalumab) & tremelimumab and 3 radiation treatments delivered on 3 different days. (each dose of radiation will be given to a higher dose than in group 3)

Group 3 will receive MEDI4736 (durvalumab) & tremelimumab and 4 radiation treatments delivered twice a day for 2 days during each of the first 4 cycles of treatment (each dose of radiation will be given to a lower dose than in group 2).

Participating Institutions:
  • Duke University Health System : Phase I Clinical Trials Office DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Alliance A021502 (Stage III Colon Cancer)
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00087658

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Stage III Colon Cancer
What is the Purpose of this Study?
We are doing this study to find out if the study drug atezolizumab given with the usual chemotherapy is better, the same, or worse than the usual chemotherapy by itself.  
Who Can Participate in the Study?
Adults with Stage III colon cancer who:
- Have a completely resected tumor
- Have no active autoimmune disease
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Be randomized (put into one of two groups by chance like the flip of a coin) and get either:
-- Group 1: Chemotherapy plus atezolizumab for 6 months, then atezolizumab alone for 6 months
-- Group 2: Chemotherapy for 6 months
- Get a thyroid test before you begin the study drug regimen
- Get a colonoscopy within 6 weeks of completing chemotherapy 
- Be asked to complete an optional quality of life questionnaires about your physical and emotional well-being
Participating Institutions:
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

AbbVie M14-064 for Metastatic Colorectal Cancer
Principal Investigator: Strickler, John
Protocol Number: PRO00091044

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Colon

Contact: Duke Recruitment Innovation Center
Phone: 919.681.5698

What is the Condition Being Studied?
Colorectal Cancer
What is the Purpose of this Study?
We are doing this study to find if the study drug called ABT-165 given in combination with
the standard of care treatment, FOLFIRI, will work better than an approved standard treatment
combination for metastatic colorectal cancer.
Who Can Participate in the Study?
Adults who:
- Have colorectal cancer 
- Have received prior therapy that included a fluoropyrimidine, oxaliplatin, and bevacizumab
What is Involved?
If you choose to join this study you will:
- Be randomized (like the flip of a coin) to either get:
--  The study drug ABT-165 plus FOLFIRI OR Bevacizumab plus FOLFIRI through your vein
--- Infusions will be given on Day 1 of each 14-day cycle
- Have tests, exams, and procedures that are part of your standard care and for study purposes 
Participating Institutions:
  • Duke University Health System
View this trial at ClinicalTrials.gov

BLU-285-1303 for Advanced GIST
Principal Investigator: Choe, Jennifer
Protocol Number: PRO00091857

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Soft Tissue

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Locally advanced or advanced GIST (Gastrointestinal stromal tumor)
What is the Purpose of this Study?
We are doing this study to find out if a drug called avapritinib (BLU-285) will work against GIST. 
Who Can Participate in the Study?
Adults with GIST tumor who:

- Are locally advanced, but cannot be removed by surgery 

OR
 
- Advanced (spread throughout the body)

Disease has gotten worse on prior therapies with drugs called tyorisine kinase inhibitors (no more than 3 kinds)
What is Involved?
If you choose to join this study, you will:
-Be randomized (like the flip of a coin) to take either avapritinib or regoarafenib by the mouth every day.
- Have study visits once a month at Duke
Participating Institutions:
  • Duke Cancer Center Cary : Sarcoma DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Sarcoma DCI Clinical Research Team
  • Duke Primary Care : Sarcoma DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Sarcoma DCI Clinical Research Team
  • Duke Raleigh Hospital : Sarcoma DCI Clinical Research Team
  • Duke Regional Hospital : Sarcoma DCI Clinical Research Team
  • Duke University Health System : Sarcoma DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Sarcoma DCI Clinical Research Team
  • Johnston Health (Smithfield) : Sarcoma DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Sarcoma DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Sarcoma DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Nektar-262: Colorectal Cancer
Principal Investigator: Strickler, John
Protocol Number: PRO00094387

Age Group: Adult
Scope:

Phase: I/II
Disease Site: Colon

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Colorectal Cancer
What is the Purpose of this Study?
We are doing this study to test if the doublet and triplet study drugs are safe for patients, and also to test if they can work to slow down the growth of your tumor or make it smaller. 
Who Can Participate in the Study?
Adults who:
- Have diagnosed colorectal cancer
- Have had 2 anti-cancer therapies which did not work
- Have tumors large enough to be injected
What is Involved?
If you choose to join this study you will:
- Be assigned to get either the doublet, or the triplet study drugs (like the flip of a coin)
-- In both the doublet and the triplet study drug procedures you will be given NKTR-262 by injection straight into your tumor in the clinic at Duke on Day 1 of the first 3 cycles
-- Each study cycle lasts 21 days
- You will then be given NKTR-214 in the vein over 30 minutes, after you get NKTR-262 and Opdivo in the vein (for triplet study drug participants only) over 30 minutes following NKTR-214, beginning at Cycle 1.
Participating Institutions:
  • Duke Cancer Center Cary : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Primary Care : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Regional Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Gastrointestinal Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Gastrointestinal Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Gastrointestinal Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Gastrointestinal Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

AMG 510 for Colorectal and Non-Small Cell Lung Cancers
Principal Investigator: Strickler, John
Protocol Number: PRO00100212

Age Group: Adult
Scope:

Phase: I
Disease Site: Colon; Lung; Rectum

Contact: Duke Recruitment Innovation Center
Phone: 919.681.5698

What is the Condition Being Studied?
Colorectal Cancer and Non-Small cell Lung Cancer
What is the Purpose of this Study?
We are doing this study to find out if a new study drug, AMG 510, for colorectal cancer patients with a specific genetic mutation is safe and if your body can handle the potential side effects. 

We will also try to find what dose of the study drug is safe for patients to take. 
Who Can Participate in the Study?
Adults who: 
-Have colorectal or non-small cell lung cancer with a documented KRAS p.G12C mutation
- Are considered non-small cell lung cancer patients (you must have had prior treatment with platinum-based combination therapy and/or targeted therapies)
-Are considered colorectal cancer participants (you must have had prior treatment with 2 prior systemic therapies)
What is Involved?
If you choose to join this study, you will:
- Take the study drug, AMG 510, by mouth, once a day
--The study drug regimen will be given in 3 week cycles
--During each cycle, you will need to visit the clinic 5 times during the first cycle, 2 times during the second cycle, and once per cycle for all the remaining cycles
-The cycles of the study drug regimen that you will receive will depend on the side effects that you get
-During your clinic visits blood samples and other procedures will be performed
Participating Institutions:
  • Duke Cancer Center Cary
  • Duke Center for Living/Sarah Stedman Nutrition
  • Duke Primary Care
  • Duke Private Diagnostic Clinic (PDC)
  • Duke Raleigh Hospital
  • Duke Regional Hospital
  • Duke University Health System
  • Duke Women's Cancer Care Raleigh (Macon Pond)
  • Johnston Health (Smithfield)
  • Maria Parham Health (Henderson)
  • Scotland Health Care System (Laurinburg)
  • Southeastern Regional Medical Center (Lumberton)
View this trial at ClinicalTrials.gov

Merck 3475 for Gastric and Esophageal Cancer
Principal Investigator: Uronis, Hope
Protocol Number: PRO00100448

Age Group: Adult
Scope:

Phase: III
Disease Site: Esophagus

Contact: DCI Clinical Research Team, Gastrointestinal Oncology
Email:

What is the Condition Being Studied?
Stomach and Esophagus Cancer
What is the Purpose of this Study?
We are doing this study to compare the anti- tumor activitivy when the study drug, pembrolizumab, is given with trastuzumab and standard of care chemotherapy versus trastuzumab with placebo (an inactive pill) and chemotherapy.

We also want to test to see if it is safe, how well the drug combination works, and how your body handles the study drug if you do not receive the placebo.
Who Can Participate in the Study?
Adults who:
- Are at least 18 years of age  
- Have confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma
What is Involved?
If you choose to join this study, you will: 
- Be randomly assigned (like a flip of a coin) to get either pembrolizumab (study drug) or placebo which is an inactive pill (along with trastuzumab and standard of care chemotherapy)
-- These will be given through an IV on Day 1 of each 3 week cycle
-- Depending on the side effects you may experience will decide how many cycles of the study drug you will get
- Have a study visit once every 3 weeks
-- During your clinic visits, blood samples and other procedures will be performed
- Have tests, exams, and procedures that are part of your standard care and for study purposes
Participating Institutions:
  • Duke Cancer Center Cary : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Primary Care : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Regional Hospital : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke University Health System : Gastrointestinal Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Gastrointestinal Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Gastrointestinal Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Gastrointestinal Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Gastrointestinal Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Gastrointestinal Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov