Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors
- 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
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
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of lenalidomide
Tarek M. Mekhail, MD
Case Comprehensive Cancer Center
United States: Food and Drug Administration