|
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer conditions. Clinical Trials Search.org is a site devoted 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 take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, 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 for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
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 Adenocarcinoma Of The Rectum Studies:
1. Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
2. Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
3. Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
4. Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
5. Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Related Studies:
Other adenocarcinoma of the rectum Clinical Trials
Other Clinical Trials
Other Villejuif Clinical Trials
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
|
|
|
|
|
|
|
|
