Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

NCT00303745 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2008-07-24

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

Conditions

Interventions

DRUG

irinotecan hydrochloride

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Emmanuel Mitry, MD, PhD · Hopital Ambroise Pare

  • Thomas Aparicio · Hopital Bichat - Claude Bernard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00303745 on ClinicalTrials.gov