Status:
COMPLETED
Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan
Lead Sponsor:
University of New Mexico
Conditions:
Solid Tumors
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Capecit...
Detailed Description
RATIONALE: Many studies have tested the combination of cisplatin and irinotecan. Side effects have been well described. The two drugs are synergistic. The standard of care for colon cancer is the com...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00249977
Start Date
April 1 2003
End Date
January 1 2009
Last Update
January 7 2010
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131