Gastrointestinal (GI) Cancer Treatment Trials
Masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced stage or metastatic pancreatic cancer (SLHN 2008-56)
Purpose
The purpose of this study is to compare the results and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced stage or metastatic (spreading) pancreatic cancer.
Further Study Information
Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine. Based on various studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.
Eligibility Criteria
- Confirmed adenocarcinoma of the pancreas
- Chemo naïve patients with advanced stage or metastatic cancer
- Documented decision justifying non eligibility for surgical resection (complete surgical removal of the tumor). In addition, this documentation will be reviewed by an independent committee to verify non eligibility for surgical resection
- Men and women, older 18 years
- Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake
- Patient should be able and willing to comply with study visits and procedures as determined by the protocol (treatment plan designed by the study)
- Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed
- No patients who were treated for a cancer other than pancreatic cancer within 5 years before enrollment will be eligible, with the exception of basal cell carcinoma or cervical cancer that is located in the original position
- No conditions that the physician judges could cause the participant to become unsafe in this study
- No anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to the initial collection of information for this study
- No treatment with any investigational drug within 4 weeks prior to the initial collection of information for this study
Final eligibility is determined by the research staff.
Compare the results and safety of masitinib to imatinib in patients with gastro-intestinal stromal tumor in first line medical treatment (SLHN 2008-65)
Purpose
The objective of the study is to compare the results and safety of masitinib to imatinib in patients with gastro-intestinal stromal tumor (GIST) in first line medical treatment.
Further Study Information
Treatment may be associated with side effects and patients might develop a resistance to treatment over time. Based on pre-clinical and clinical studies, masitinib (AB1010) can be considered as a good candidate in the first line treatment of patients with GIST.
Eligibility Criteria
- Confirmed metastatic (spreading) or advanced stage non respectable, or recurrent post surgery GIST
- Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant (supplemental treatment prior to or post cancer surgery in hopes of cure) who relapsed after imatinib discontinuation
- Man or woman, older than 18 years of age
- Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake
- Patient able and willing to comply with study procedures as per protocol (treatment plan designed by the study)
Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
- Patient not previously treated by tyrosine kinase inhibitors, except imatinib in case of inclusion criteria 2
- Patient not treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in the original position
- No active central nervous system (CNS) metastasis or with history of CNS metastasis
- No grade III/IV cardiac problems as defined by the New York Heart Association Criteria or any other condition that the physician judges could be cause the participant to become unsafe during this study
- No treatment with any investigational drug within 4 weeks prior initial collection of information for the study
- No treatment by imatinib as neoadjuvant/adjuvant (supplemental treatment prior to or post cancer surgery in hopes of cure) therapy within 4 weeks prior to initial collection of information for the study
Final eligibility is determined by the research staff.
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
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Confirmed diagnosis of adenocarcinoma of the colon or rectum that has spread to other parts of the body
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Previous oxaliplatin based chemotherapy treatment for metastatic disease that did not prevent a relapse
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No prior therapy with irinotecan
Final eligibility will be determined by the research staff.
Phase II Study of Neoadjuvant Chemoradiotherapy Comprising Oxaliplatin, Fluorouracil, and Radiotherapy Combined With Cetuximab, Followed by Surgery and Adjuvant Docetaxel and Cetuximab in Patients With Resectable Adenocarcinoma of the Esophagus or Gastroesophageal Junction (ECOG 2205)
Purpose
Drugs used in chemotherapy, such as oxaliplatin, fluorouracil and docetaxel, 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after surgery.
This phase II trial is studying how well giving chemotherapy and radiation therapy together with cetuximab followed by surgery, docetaxel and cetuximab works in treating patients with esophageal cancer or gastroesophageal junction cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Newly diagnosed disease
- No previous chemotherapy, radiation therapy, or surgery
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will receive a 2-hour infusion of oxaliplatin once every other week and a 1- to 2-hour infusion of cetuximab once a week in weeks 1-5. They will also receive a 5-week continuous infusion of fluorouracil and also undergo radiation therapy 5 days a week in weeks 1-5. Patients will undergo surgery to remove the tumor.
Four to eight weeks after surgery, some patients will receive a one-hour infusion of docetaxel once a week in weeks 1 - 5 and a 1 to 2 hour infusion of cetuximab once-a-week in weeks 1-6. Treatment with docetaxel and cetuximab may repeat every six weeks for two courses.
After finishing treatment, patients will be evaluated every three months for two years and every six months for three to five years.
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.
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer (CTSU N0147)
Purpose
Drugs used in chemotherapy, such fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective after surgery in treating colon cancer.
This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work when given with or without cetuximab to see how well they work in treating patients who have undergone surgery for stage III colon cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No rectal cancer
- No more than 8 weeks since surgery to completely remove the tumor
- No spread of cancer to other parts of the body
- No previous chemotherapy or radiation therapy for colon cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned to one of two groups.
- Patients in group one will receive a 2-hour infusion of oxaliplatin and a 2-hour infusion of leucovorin on day 1. They will also receive a 2-day continuous infusion of fluorouracil beginning on day 1. Treatment may be repeated every 2 weeks for up to 12 courses.
- Patients in group two will receive a 1- to 2-hour infusion of cetuximab on days 1 and 8, and oxaliplatin, leucovorin, and fluoruracil as in group one for up to 12 courses.
Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once-a-year for up to 3 years.
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 III intergroup trial of adjuvant chemoradiation after resection of gastric or gastroesophageal carcinoma (CTSU C80101)
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy X-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy treatment is more effective in treating stomach or esophageal cancer.
Purpose
Randomized phase III trial to compare two different chemotherapy and radiation therapy treatments in patients who have undergone surgery for stomach or esophageal cancer.
Eligibility
- At least 18 years old
- No spread of the cancer to other parts of the body
- No previous chemotherapy or radiation therapy
- No more than eight weeks since surgery
Treatment Intervention
Patients will be randomly assigned to one of two groups. The chemotherapy drugs used in this study are leucovorin, fluorouracil, epirubicin and cisplatin.
- Patients in group one will receive a total of four courses of therapy. During courses one, three, and four patients will receive infusions of leucovorin and fluorouracil. During course two, they will undergo radiation therapy five days a week and will receive a continuous infusion of fluorouracil for five weeks. Patients will have a one-month rest period between courses two and three.
- Patients in group two will receive a total of two courses of therapy. During course one, they will receive infusions of epirubicin and cisplatin on day one and a three-week continuous infusion of fluorouracil. Patients will then have a one-week rest period followed by radiation therapy five days a week and a five-week continuous infusion of fluorouracil. After a four- to five-week rest period, patients will begin course two and will receive infusions of epirubicin, cisplatin, and fluorouracil as in course one.
All patients will be evaluated every three months for two years, every four months for two years and once-a-year for three years.
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.
Intergroup randomized Phase III study of postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for patients with stage II or III rectal cancer receiving pre-operative chemoradiation (E5204)
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 more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer.
This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have undergone surgery for stage II or stage III rectal cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Has undergone surgery to completely remove the tumor within the past 4 to 8 weeks
- Received chemotherapy and radiation therapy before undergoing surgery
- No other previous chemotherapy or radiation therapy to the pelvis
- More than four weeks since surgery or open 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) to one of two treatment groups.
- Patients in group one will receive two-hour infusions of oxaliplatin and leucovorin and an infusion of fluorouracil on day 1. They will also receive a two-day continuous infusion of fluorouracil beginning on day 1. Treatment may repeat every two weeks for up to 12 courses. Some patients may receive up to nine courses of treatment followed by infusions of leucovorin and fluorouracil with or without bevacizumab for up to three courses.
- Patients in group two will receive a 30- to 90-minute infusion of bevacizumab, two-hour infusions of oxaliplatin and leucovorin, and an infusion of fluorouracil on day 1. They will also receive a two-day continuous infusion of fluorouracil beginning on day 1. Treatment may repeat every two weeks for up to 12 courses. Some patients may receive up to nine courses of treatment followed by infusions of leucovorin and fluorouracil with or without bevacizumab for up to three courses.
Patients also will complete questionnaires about bowel function four times during treatment.
After finishing treatment, patients will be evaluated periodically for approximately ten 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.