Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.
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
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Progressing disease or unacceptable toxicities
Claire F Verschraegen, MD
University of New Mexico
United States: Institutional Review Board
|University of New Mexico||Albuquerque, New Mexico 87131|