Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma
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|ClinicalTrials.gov Identifier: NCT00038246|
Recruitment Status : Completed
First Posted : May 30, 2002
Last Update Posted : June 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Estramustine Drug: Thalidomide Drug: Paclitaxel (Taxol)||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (AI-PCa)|
|Study Start Date :||October 2000|
|Primary Completion Date :||February 2004|
|Study Completion Date :||December 2004|
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
- Maximum tolerated dose (MTD) Thalidomide [ Time Frame: 21 day cycles ]MTD defined by Continuous reassessment method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038246
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Christopher J. Logothetis, MD||UT MD Anderson Cancer Center|