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Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006112   Information provided by National Cancer Institute (NCI)
First Received: August 3, 2000   Last Updated: February 6, 2009   History of Changes

August 3, 2000
February 6, 2009
January 1996
 
 
 
Complete list of historical versions of study NCT00006112 on ClinicalTrials.gov Archive Site
 
 
 
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
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

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.

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.

Phase II
Interventional
Treatment
  • Carcinoma of the Appendix
  • Colorectal Cancer
  • Peritoneal Cavity Cancer
  • Drug: chemotherapy
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Drug: mitomycin C
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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

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

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Both
 
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00006112
 
CDR0000068124, FRE-IGR-95/040/434-SUGAR, EU-20012
Institut Gustave Roussy
 
Study Chair: Dominique Elias, MD Institut Gustave Roussy
National Cancer Institute (NCI)
May 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP