NCT00006112

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

May 4, 2004

Completed
Last Updated

April 26, 2011

Status Verified

May 1, 2001

First QC Date

August 3, 2000

Last Update Submit

April 23, 2011

Conditions

Carcinoma of the AppendixColorectal CancerPrimary Peritoneal Cavity Cancer

Keywords

stage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectumcarcinoma of the appendixprimary peritoneal cavity cancer

Interventions

chemotherapyDRUG
fluorouracilDRUG
leucovorin calciumDRUG
mitomycin CDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Appendiceal NeoplasmsColorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Drug TherapyFluorouracilLeucovorinMitomycin

Condition Hierarchy (Ancestors)

Cecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesColonic DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesIndoles

Study Officials

  • Dominique Elias, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2000

First Posted

May 4, 2004

Study Start

January 1, 1996

Last Updated

April 26, 2011

Record last verified: 2001-05

Locations

FR(1)