Trials / Completed
CompletedNCT00024141
Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluorouracil | |
| DRUG | irinotecan hydrochloride |
Timeline
- Start date
- 2001-05-01
- Primary completion
- 2002-09-01
- Completion
- 2003-01-01
- First posted
- 2003-06-20
- Last updated
- 2011-03-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00024141. Inclusion in this directory is not an endorsement.