Lenalidomide, Docetaxel, and Carboplatin in Treating Patients With Advanced Solid Tumors
RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 and carboplatin 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 and carboplatin in treating patients with advanced solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors|
- Maximum tolerated dose of lenalidomide [ Designated as safety issue: Yes ]
- Dose-limiting toxicity of lenalidomide [ Designated as safety issue: Yes ]
- Safety and toxicity [ Designated as safety issue: Yes ]
- Clinical activity [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of lenalidomide when administered with docetaxel and carboplatin in patients with advanced solid tumors.
- Determine the safety and toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of lenalidomide.
Patients receive docetaxel IV over 1 hour followed by carboplatin IV on day 1. Patients also receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of 6 courses of treatment may continue lenalidomide alone once daily on days 1-14. Patients whose disease is stable or responding after completing 2 or 4 courses and who are unable to tolerate further chemotherapy may continue lenalidomide alone once daily on days 1-14, at the investigator's discretion. Treatment with lenalidomide repeats every 21 days in the absence of 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 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-8 patients are treated at the MTD.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
|Study Chair:||Tarek M. Mekhail, MD||Case Comprehensive Cancer Center|