Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00024141|
Recruitment Status : Completed
First Posted : June 20, 2003
Last Update Posted : March 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: fluorouracil Drug: irinotecan hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study|
|Study Start Date :||May 2001|
|Primary Completion Date :||September 2002|
|Study Completion Date :||January 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|