Overview

Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of New Mexico
Treatments:
Camptothecin
Capecitabine
Cisplatin
Irinotecan
Criteria
Inclusion Criteria:

- All patients, 18 years of age or older, with incurable advanced cancer for whom there
is no effective therapy are eligible.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence
of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during this
trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

- Patients whose cancer progressed while receiving 5-FU, cisplatin or irinotecan.