NCT00249977

Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 combination of 5-FU, leucovorin and irinotecan (Saltz regimen). Recently, oxaliplatin has been introduced for the treatment of colon cancer. Combination of oxaliplatin with 5FU (Folfox4) have shown comparable activity to the Saltz regimen. Furthermore, one author recently published on the triple combination of oxaliplatin, 5FU and irinotecan, with impressive clinical activity in colon cancer. There is some evidence that 5FU impairs DNA repair. One of the putative resistance mechanism to topoisomerase I inhibitors is increased DNA repair. We therefore hypothesize that inhibition of DNA repair by capecitabine may increase the activity of the combination of cisplatin and irinotecan. This study is open to all patients with solid tumor who have failed a line of chemotherapy

Conditions

• Solid Tumors
• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-04-01
• Primary completion: 2007-08-01
• Completion: 2009-01-01
• First posted: 2005-11-07
• Last updated: 2010-01-07

Locations

1 site across 1 country: United States