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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082693 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Combining thalidomide with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining paclitaxel and estramustine with thalidomide in treating patients who have progressive metastatic androgen-independent prostate cancer.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: estramustine phosphate sodium Drug: paclitaxel Drug: thalidomide |
Phase I Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Thalidomide Paclitaxel Estramustine Estramustine phosphate Estramustine phosphate sodium |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (Al-PCa) |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of paclitaxel and thalidomide followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 48-75 patients (18 for phase I and 30-57 for phase II) will be accrued for this study within 8-15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma* of the prostate
Progressive androgen-independent disease, as evidenced by the following:
Testosterone ≤ 50 ng/dL OR prior bilateral orchiectomy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
More than 12 weeks since prior strontium chloride Sr 89
Surgery
Other
United States, Texas | |||||
University of Texas - MD Anderson Cancer Center | |||||
Houston, Texas, United States, 77030-4009 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Danai Daliani | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000355825, MDA-ID-00087 |
First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082693 |
Health Authority: | United States: Federal Government |
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