Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan
Completed · Phase 1
Conditions studied: Solid Tumors, Cancer
In brief
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.
Key facts
- Study ID
- NCT00249977
- Run by
- University of New Mexico
- People needed
- 21
- Starts
- 2003-04-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2010-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of New Mexico — Albuquerque, New Mexico, United States
Full record on ClinicalTrials.gov
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