Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006112
First received: August 3, 2000
Last updated: April 23, 2011
Last verified: May 2001
  Purpose

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 Intervention Phase
Carcinoma of the Appendix
Colorectal Cancer
Primary Peritoneal Cavity Cancer
Drug: chemotherapy
Drug: fluorouracil
Drug: leucovorin calcium
Drug: mitomycin C
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1996
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006112

Locations
France
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Dominique Elias, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006112     History of Changes
Other Study ID Numbers: CDR0000068124, FRE-IGR-95/040/434-SUGAR, EU-20012
Study First Received: August 3, 2000
Last Updated: April 23, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
carcinoma of the appendix
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Peritoneal Neoplasms
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Abdominal Neoplasms
Peritoneal Diseases
Mitomycins
Mitomycin
Fluorouracil
Leucovorin
Levoleucovorin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014