Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00096317|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : October 31, 2018
RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving ixabepilone with ketoconazole may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: ixabepilone Drug: ketoconazole||Phase 1|
- Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients with advanced solid tumors.
- Determine the safety of ixabepilone when administered alone and in combination with ketoconazole in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of ixabepilone.
During course 1, patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3 hours on day 1. During course 2 and subsequent courses, patients receive only ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. At least 12 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Ketoconazole on the Pharmacokinetics and Pharmacodynamics of Ixabepilone In Patients With Advanced Cancer|
|Actual Study Start Date :||March 2003|
|Actual Primary Completion Date :||December 5, 2005|
|Actual Study Completion Date :||December 5, 2005|
- Effect of ketoconazole on the pharmacokinetics of ixabepilone
- Safety of ixabepilone with and without ketoconazole
- Antitumor activity
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): NCT00096317
|United States, New York|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Study Chair:||Sridhar Mani, MD||Albert Einstein College of Medicine|