Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma|
- Response (complete and partial response)
- Time to progression
- Overall survival
- Clinical benefit
|Study Start Date:||March 2002|
- Determine the efficacy of temozolomide and thalidomide in patients with metastatic, locally advanced, or unresectable leiomyosarcoma.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients.
OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033709
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|Study Chair:||Robert N. Taub, MD, PhD||Herbert Irving Comprehensive Cancer Center|