Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003710|
Recruitment Status : Completed
First Posted : April 9, 2004
Last Update Posted : August 9, 2012
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 irinotecan plus mitomycin in treating patients who have advanced solid tumors that are persistent or recurrent.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Drug: mitomycin C||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of mitomycin when administered with irinotecan in patients with advanced solid tumors. II. Determine whether the pharmacokinetic profile of irinotecan is altered by prior administration of mitomycin in this patient population. III. Determine the effect of irinotecan and mitomycin on the expression of DT-Diaphorase and the Topo I gene. IV. Determine the preliminary antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I and Pharmacokinetic Study of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Solid Tumors|
|Study Start Date :||August 1998|
|Actual Primary Completion Date :||May 2001|
|Actual Study Completion Date :||May 2001|
Drug: irinotecan hydrochloride
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): NCT00003710
|United States, Texas|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Ronald L. Drengler, MD||South Texas Oncology and Hematology - Wurzbach Road|