Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma of the Appendix; Colorectal Cancer; Primary Peritoneal Cavity Cancer
Intervention: chemotherapy (Drug); fluorouracil (Drug); leucovorin calcium (Drug); mitomycin C (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Gustave Roussy, Cancer Campus, Grand Paris Official(s) and/or principal investigator(s): Dominique Elias, MD, Study Chair, Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Summary
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.
Clinical Details
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 design: Primary Purpose: Treatment
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Institut Gustave Roussy, Villejuif F-94805, France
Additional Information
Starting date: January 1996
Last updated: April 23, 2011
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