Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00006112|
Recruitment Status : Unknown
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 4, 2004
Last Update Posted : April 26, 2011
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.
PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of the Appendix Colorectal Cancer Primary Peritoneal Cavity Cancer||Drug: chemotherapy Drug: fluorouracil Drug: leucovorin calcium Drug: mitomycin C||Phase 2|
OBJECTIVES: I. Compare the efficacy of adjuvant systemic fluorouracil with intraperitoneal mitomycin vs systemic fluorouracil alone in terms of survival in patients with peritoneal cancer originating from the colorectum.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and mode of surgery. Patients are randomized to one of two treatment arms. Arm I: Patients undergo complete resection of tumor on day 0. Patients then receive mitomycin intraperitoneally (IP) over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5. Patients then receive one of three systemic chemotherapy regimens for 6 months: Regimen I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 2 weeks. Regimen II: Patients receive fluorouracil IV continuously for 7 weeks. Treatment repeats every 8 weeks. Regimen III: Leucovorin calcium and fluorouracil are administered as per standard procedure. Arm II: Patients receive treatment as in arm I but without early intraperitoneal chemotherapy. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: At least 90 patients (45 per arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum|
|Study Start Date :||January 1996|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006112
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Dominique Elias, MD||Gustave Roussy, Cancer Campus, Grand Paris|