Gastrointestinal (GI) Cancer Treatment Trials
A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Adenocarcinoma (ACOSOG Z5041)
Purpose
Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.
This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancerthat can be removed by surgery.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No spread of cancer to other parts of the body
- No previous therapy for pancreatic cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention
Patients will receive an infusion of gemcitabine once in weeks 1-3 and 5-7. They will also receive erlotinib by mouth once a day for approximately 6 weeks. Three to 6 weeks later, patients will undergo surgery. Beginning 5-10 weeks after surgery, patients will receive an infusion of gemcitabine once in weeks 1-3 and 5-7 and erlotinib by mouth once a day for approximately 6 weeks.
Patients will undergo blood and tumor tissue sample collection for laboratory studies.
After finishing treatment, patients will be evaluated every 3 months for 2 years and every 6 months for 2 years.
Phase II Study of Neoadjuvant Panitumumab, Docetaxel, Cisplatin, and Radiotherapy Followed By Surgery in Patients With Newly Diagnosed, Locally Advanced Adenocarcinoma of the Distal Esophagus or Gastroesophageal Junction (ACOSOG Z4051)
Purpose
Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy X-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
This phase II trial is studying how well giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No spread of cancer to other parts of the body
- No previous radiation therapy to the chest or upper abdomen
- No previous cisplatin, docetaxel, or panitumumab
- No previous surgery to the esophagus or stomach
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention
Patients will receive a 1-hour infusion of panitumumab, a 1-hour infusion of docetaxel, and a 1- to 2-hour infusion of cisplatin in weeks 1, 3, 5, 7 and 9. Beginning in weeks 5, patients will undergo radiation therapy 5 days a week for up to 5½ weeks. Approximately 6-9 weeks after finishing chemotherapy and radiation therapy, some patients will undergo surgery.
After finishing treatment, patients will be evaluated every 3-6 months for 3 years.
Effectiveness of Aflibercept in increasing the overall survival in patients with metastatic colorectal cancer treated with Irinotecan and 5-FU (EFC 10262)
Purpose
The main goal of the study is to evaluate the effectiveness of aflibercept in increasing the overall survival in patients with metastatic colorectal cancer treated with irinotecan and 5-FU and that have previously failed an oxaliplatin based treatment for metastatic disease.
Eligibility Criteria
- Confirmed diagnosis of adenocarcinoma of the colon or rectum that has spread to other parts of the body
- Previous oxaliplatin based chemotherapy treatment for metastatic disease that did not prevent a relapse
- No prior therapy with irinotecan
Final eligibility will be determined by the research staff.
Phase III Randomized Study of Chemoradiotherapy Comprising Paclitaxel, Cisplatin and Radiotherapy With Versus Without Cetuximab in Patients With Locally Advanced Esophageal Cancer (RTOG 0436)
Purpose
Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy X-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating patients with locally advanced esophageal cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No previous chemotherapy for this cancer
- No previous chemotherapy that includes drugs such as paclitaxel, cisplatin, or carboplatin
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will receive a 1- to 2-hour infusion of cetuximab, a 1-hour infusion of paclitaxel, and a 30- to 60-minute infusion of cisplatin once a week in weeks 1- 6. At the same time, patients will undergo radiation therapy 5 days a week for 5½ weeks.
- Patients in group two will receive a 1-hour infusion of paclitaxel and a 30- to 60-minute infusion of cisplatin once a week for 6 weeks. Patients will also undergo radiation therapy 5 days a week for 5½ weeks.
No more than 6 to 8 weeks after finishing radiation therapy, patients will undergo endoscopy. Patients complete quality of life questionnaires before beginning treatment, within one week after endoscopy, and at one and two years from beginning of treatment.
After finishing treatment, patients will be evaluated periodically.
Phase III Randomized Study of Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Bevacizumab in Patients With Resected Stage II Colon Cancer and at High Risk for Recurrence Based on Molecular Markers (E5202)
Purpose
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any remaining tumor cells or prevent the cancer from coming back. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone or observation only in treating colon cancer.
This randomized phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Has undergone surgery to remove the tumor between the past one to two months
- No previous radiation therapy for this cancer
- More than four weeks since surgery or open biopsy
- No previous systemic therapy for this cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Some patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups. Other patients will be assigned to group three.
- Patients in group one will receive a two-hour infusion of oxaliplatin and a two-hour infusion of leucovorin once in week one. They will also receive a two-day continuous infusion of fluorouracil in week one. Treatment may repeat every two weeks for up to 12 courses.
- Patients in group two will receive a two-hour infusion of oxaliplatin and a two-hour infusion of leucovorin once in week one. They will also receive a two-day continuous infusion of fluorouracil and a 30- to 90-minute infusion of bevacizumab once in week one. Treatment may repeat every two weeks for up to 12 courses. Patients will then receive bevacizumab alone for up to 12 additional courses.
- Patients in group three will undergo observation only.
Patients will be evaluated every three months for one to two years, every six months for three years, and once-a-year for up to 10 years from study entry.
Phase II study of treatment selection based upon tumor thymidylate synthase expression in previously untreated patients with metastatic colorectal cancer (ECOG 4203)
Purpose
Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment.
This randomized phase II trial is studying giving bevacizumab, oxaliplatin and irinotecan or giving bevacizumab, oxaliplatin, leucovorin and fluorouracil in treating patients with metastatic or recurrent colorectal cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Disease that has spread to other parts of the body
- More than four weeks since surgery or biopsy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed in one of three treatment groups).
- Patients in group one will receive a 30-90 minute infusion of bevacizumab, a two-hour infusion of oxaliplatin, and a 90-minute infusion of irinotecan in weeks one and three.
- Patients in groups two and three will receive bevacizumab and oxaliplatin as in group one, a two-hour infusion of leucovorin and a two-day continuous infusion of fluorouracil in weeks one and three.
In all groups, treatment may repeat every four weeks for as long as benefit is shown.
Patients will be evaluated periodically for four years.
Phase III Randomized Study of Cetuximab and/or Bevacizumab in Combination With Either Oxaliplatin, Fluorouracil, and Leucovorin Calcium (FOLFOX) OR Irinotecan Hydrochloride, Fluorouracil, and Leucovorin Calcium (FOLFIRI) in Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum (CTSU 80405)
Purpose
Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.
This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No spread of cancer to the brain or spinal cord
- No previous bevacizumab or cetuximab
- At least 4 weeks since radiation therapy or surgery
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.
- Patients in group one will receive a two-hour infusion of oxaliplatin or a 30- to 90-minute infusion of irinotecan; a two-hour infusion of leucovorin; a two-day continuous infusion of fluorouracil; and a 30- to 90-minute infusion of bevacizumab in weeks 1, 3, 5, and 7. Treatment may repeat every eight weeks for at least two courses.
- Patients in group two will receive a two-hour infusion of oxaliplatin or a 30- to 90-minute infusion of irinotecan; a two-hour infusion of leucovorin; and a two-day continuous infusion of fluorouracil in weeks 1, 3, 5, and 7. They also will receive a one- to two-hour infusion of cetuximab once-a-week for eight weeks. Treatment may repeat every eoght weeks for at least two courses.
- Patients in group three will receive a two-hour infusion of oxaliplatin or a 30- to 90-minute infusion of irinotecan; a two-hour infusion of leucovorin; a two-day continuous infusion of fluorouracil; and a 30- to 90-minute infusion of bevacizumab in weeks 1, 3, 5, and 7. They also will receive a one- to two-hour infusion of cetuximab once-a-week for eight weeks. Treatment may repeat every 8 weeks for at least two courses.
After finishing treatment, patients will be evaluated periodically for five years and once-a-year thereafter.