Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan
- To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan.
- To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.
- To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.
|Solid Tumors Cancer||Drug: Capecitabine in Combination with Cisplatin and Irinotecan||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.|
- To determine the safety/feasibility of Capecitabine with the combination of Cisplatin and Irinotecan. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan. [ Time Frame: Progressing disease or unacceptable toxicities ]
- To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy. [ Time Frame: disease progression, unacceptable toxicities ]
|Study Start Date:||April 2003|
|Study Completion Date:||January 2009|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249977
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Claire F Verschraegen, MD||University of New Mexico|