Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: fluorouracil Drug: irinotecan hydrochloride||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study|
|Study Start Date:||May 2001|
|Study Completion Date:||January 2003|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
- Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients.
- Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose de-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024141
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Patrick J. Creaven, MBBS, PhD||Roswell Park Cancer Institute|