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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038246 |
The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Thalidomide, Taxol, Estramustine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (AI-PCa) |
Estimated Enrollment: | 57 |
Study Start Date: | October 2000 |
2A. The objective response rate and ?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.
3. To evaluate the toxicity of the combination treatment in patients with metastatic AI-PCa progressing after chemotherapy.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion:
Androgen-Independent progression of prostate carcinoma, as shown by:
Adequate physiologic reserve as evidenced by:
Exclusion:
Study ID Numbers: | ID00-087 |
Study First Received: | May 29, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00038246 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer |
Immunologic Factors Genital Neoplasms, Male Prostatic Diseases Thalidomide Antineoplastic Agents, Hormonal Estramustine Urogenital Neoplasms Genital Diseases, Male Angiogenesis Inhibitors |
Immunosuppressive Agents Carcinoma Anti-Bacterial Agents Paclitaxel Antineoplastic Agents, Alkylating Prostatic Neoplasms Alkylating Agents Androgens |
Anti-Infective Agents Thalidomide Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Estramustine Physiological Effects of Drugs Urogenital Neoplasms Anti-Bacterial Agents Neoplasms by Site Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Antineoplastic Agents, Hormonal Growth Substances Genital Diseases, Male Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Antineoplastic Agents, Alkylating Prostatic Neoplasms Leprostatic Agents |