Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00253344|
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : June 11, 2010
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: docetaxel Drug: lenalidomide||Phase 1|
- Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors.
- Determine the safety of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.
Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of lenalidomide 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.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||June 2008|
- Drug: docetaxel
Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
- Drug: lenalidomide
Oral lenalidomide on days 1-14. Courses repeat every 21 days until disease progression or unacceptable toxicity.
- Maximum tolerated dose [ Time Frame: measured at end of phase I ]
- Dose-limiting toxicity [ Time Frame: measured after every course ]
- Disease response [ Time Frame: measured after every 2 courses ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253344
|United States, Ohio|
|Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Matthew M. Cooney, MD||Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center|