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Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies

NCT00215501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-11-02

No results posted yet for this study

Summary

The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors.

Conditions

Interventions

DRUG

Capecitabine

Orally twice a day for 14 days (dosage will vary)

DRUG

5-Fluorouracil (5-FU)

Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary

DRUG

Irinotecan

Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period

DRUG

Cisplatin

Intravenously weekly for 2 weeks followed by a one week rest period

Sponsors & Collaborators

Principal Investigators

  • Peter C. Enzinger, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2005-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00215501 on ClinicalTrials.gov