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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038246 |
Purpose
The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Estramustine Drug: Thalidomide Drug: Paclitaxel (Taxol) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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) |
| Enrollment: | 40 |
| Study Start Date: | October 2000 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Thalidomide, Taxol, Estramustine |
Drug: Estramustine
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: Thalomid
Drug: Paclitaxel (Taxol)
100 mg/m2 by vein (IV) over 3 hours Day 3 and Day 10
|
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:
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Androgen-Independent progression of prostate carcinoma, as shown by:
Adequate physiologic reserve as evidenced by:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Christopher J. Logothetis, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | Christopher J.Logothetis, MD / Professor, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038246 History of Changes |
| Other Study ID Numbers: | ID00-087 |
| Study First Received: | May 29, 2002 |
| Last Updated: | November 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate Cancer |
|
Carcinoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Androgens Estramustine Thalidomide Paclitaxel Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors |