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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer
PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.
OBJECTIVES: I. Compare the efficacy of leucovorin calcium plus fluorouracil with either irinotecan or oxaliplatin in terms of progression free survival in patients with recurrent metastatic colorectal cancer. II. Compare the efficacy, tolerance, quality of life, and overall survival in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and measurable or evaluable disease. Patients are randomized to receive either a 2 hour continuous infusion of irinotecan or a 2 hour continuous infusion of oxaliplatin on day 1. All patients receive a 2 hour continuous infusion of leucovorin calcium followed by IV bolus and 48 hour continuous infusion of fluorouracil on days 1 and 2. Courses are repeated every 2 weeks. Patients will receive the alternate treatment if disease progression or unacceptable toxicity occurs on their initial treatment. Patients are followed every 3 months after end of treatment.
PROJECTED ACCRUAL: This study will accrue a total of 109 patients per arm over approximately 18 months.
Allocation: Randomized, Primary Purpose: Treatment
FOLFIRI regimen, FOLFOX regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
Hopital Saint Antoine
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:57:03-0400
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not ye...
FOLFOX* followed by FOLFIRI** or reverse sequence treatment regimen have been used as a standard treatment modality in metastatic colorectal cancer.Oxaliplatin and Irinotecan were used for...
To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients
The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovo...
RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radi...
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. Cyclooxygenase-2 (COX-2) overexpression is associated with increased tumor invasiveness and proliferation in C...
Aflibercept combined with FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) as second-line treatment of metastatic colorectal cancer (mCRC) significantly improved survival compared with FOLFIRI alone...
Irinotecan (CPT-11) in combination with 5-fluorouracil (5FU) is widely used in the treatment of colorectal cancer. We assessed potential clinical variables that may predict toxicity and more specifica...
Conversion therapy can convert unresectable metastatic colorectal cancer (mCRC) into resectable. However, the optimal conversion regimen was not yet defined. This meta-analysis aimed to compare the ef...
The combination of oxaliplatin, leucovorin and fluorouracil (FOLFOX) has been established as postoperative adjuvant chemotherapy for stage III colon cancer. However, the safety and efficacy of neoadju...
Voluntary cooperation of the patient in following a prescribed regimen.
Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A treatment program based on manipulation of the patient's environment by the medical staff. The patient does not participate in planning the treatment regimen.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...