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Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

NCT00249977 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2010-01-07

No results posted yet for this study

Summary

1. To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan.
2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.
3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.

Conditions

Interventions

DRUG

Capecitabine in Combination with Cisplatin and Irinotecan

Cisplatin 50 mg/m2 on day 1 (course 1) or day 11 (subsequent courses) Irinotecan 50 mg/m2 on day 1, 8, and 15 (course 1) or day 11, 18 and 25 (subsequent courses). Capecitabine will be administered from day 1 to day 10 PO starting on course 2.

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Claire F Verschraegen, MD · University of New Mexico

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
2003-04-30
Primary Completion
2007-08-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00249977 on ClinicalTrials.gov