Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma
The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.
Drug: Paclitaxel (Taxol)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (AI-PCa)|
- Maximum tolerated dose (MTD) Thalidomide [ Time Frame: 21 day cycles ] [ Designated as safety issue: Yes ]MTD defined by Continuous reassessment method.
|Study Start Date:||October 2000|
|Study Completion Date:||December 2004|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
Experimental: Thalidomide, Taxol, Estramustine
Thalidomide starting dose 200 mg by mouth every day once a week; Taxol 100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10; Estramustine 140 mg by mouth three times a day on Days 1-5, 8-12.
140 mg by mouth (po) three times a day on Days 1-5, 8-12
Other Names:Drug: Thalidomide
200 mg by mouth every day once a week with dose escalation every week if no dose limiting toxicity.
Other Name: ThalomidDrug: Paclitaxel (Taxol)
100 mg/m^2 by vein (IV) over 3 hours Day 3 and Day 10
- Evaluate the maximum tolerated dose of oral daily thalidomide along with Paclitaxel (100 mg/m^2 as a 3-hour infusion weekly * 2, every 21 days) and oral estramustine phosphate (140 mg by mouth three times/day 5 days per week * 2 weeks, every 21 days) for patients with metastatic androgen-independent prostate carcinoma.
Evaluate the efficacy of this regimen for patients with metastatic Androgen-Independent Prostate Cancer who failed up to two prior non-paclitaxel containing chemotherapy regimens, as measured by:
- 2A. The objective response rate and 'prostate-specific antigen (PSA) response rate' of the combination treatment in patients with AI-PCa progressing after chemotherapy.
- 2B. Secondary endpoints: calculate time to disease progression, effect on performance status, analgesic consumption, and survival.
- To evaluate the toxicity of the combination treatment in patients with metastatic AI-PCa progressing after chemotherapy.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Christopher J. Logothetis, MD||UT MD Anderson Cancer Center|