Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00054288|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : January 13, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride||Phase 1|
- Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors.
- Determine the antitumor activity and toxicity of this regimen in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
- Determine the optimal dose and time interval for this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||May 2003|
|Actual Study Completion Date :||June 2009|
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): NCT00054288
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Nithya Ramnath, MD||Roswell Park Cancer Institute|