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Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer Clinical research trials and Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer. Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer  Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
For Condition: adenocarcinoma of the rectum,Stage 4 rectal cancer,childhood gastrointestinal cancer,peritoneal cavity cancer,adenocarcinoma of the colon,carcinoma of the appendix,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): Institut Gustave Roussy ,
Synopsis: 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 that began in the colon and rectum.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven peritoneal cancer that is amenable to total resection; Originated as colorectal adenocarcinoma or cancer of the appendix; No diffuse (unresectable) tumors; No microscopic cancer only - No hepatic, lymph node, or extraabdominal metastases on the preoperative work-up - No primitive peritoneal mesothelioma - No peritoneal pseudomyxomas or ascites - No cancer that originates as ovarian or neuroendocrine cancer, especially sarcomas (intra- or retroperitoneal) - Complete resection of tumor deposit - No originating cancer of unknown origin --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: Not specified - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: WBC greater than 1,500/mm3; Platelet count greater than 100,000/mm3; No chronic hematologic disorder; No coagulation disorder - Hepatic: Not specified - Renal: Creatinine less than 1.36 mg/dL - Other: No significant medical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DominiqueElias, Study Chair, Institut Gustave Roussy
Institut Gustave Roussy
Villejuif, , F-94805
France
Additional Information:
Study ID Numbers: CDR0000068124; FRE-IGR-95/040/434-SUGAR,EU-20012
Study Start Date: January 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006112
Other Childhood Gastrointestinal Cancer Studies:
1. Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
2. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
3. Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
4. Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
5. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Related Studies:
Other childhood gastrointestinal cancer Clinical Trials
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Other Villejuif Clinical Trials
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
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