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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00933426 |
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostate cancer who have failed treatment with taxanes.
The goal of the Phase II part of this clinical research study is to learn if lenalidomide and paclitaxel can help to control prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Lenalidomide Drug: Paclitaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Modular Phase I-II Trial of Lenalidomide and Paclitaxel in Men With Castration-Resistant Prostate Cancer and Lymph-Node Dominant Metastases |
Estimated Enrollment: | 72 |
Study Start Date: | August 2009 |
Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lenalidomide and Paclitaxel: Experimental
Phase I: Up to 5 differing doses of Lenalidomide tested plus fixed dose of Paclitaxel. Phase II: Lenalidomide at highest tolerated dose from Phase I plus Paclitaxel. |
Drug: Lenalidomide
Lead-In beginning dose of 5 mg capsules by mouth once a day for 21 days in a row, followed by 7 days of rest (Days 22-28) for a 28 day cycle.
Drug: Paclitaxel
50 mg/m^2 given by vein over 1 hour on Days 1, 8, and 15 of each 28 day cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks.
For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of
Exclusion Criteria:
Patients receiving any concurrent biological, immunological, second-line hormonal therapy or chemotherapy.
Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
Contact: Lance Pagliaro, MD | 713-792-2830 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Lance Pagliaro, MD |
Study Chair: | Lance Pagliaro, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Lance Pagliaro, MD / Associate Professor ) |
Study ID Numbers: | 2008-0606 |
Study First Received: | July 3, 2009 |
Last Updated: | August 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00933426 History of Changes |
Health Authority: | United States: Institutional Review Board |
Castration-Resistant Prostate Cancer CRPC Prostate Lenalidomide Revlimid |
CC-5103 Paclitaxel Taxol Taxanes |
Prostatic Diseases Genital Neoplasms, Male Paclitaxel Tubulin Modulators Lenalidomide Neoplasm Metastasis |
Urogenital Neoplasms Antimitotic Agents Genital Diseases, Male Antineoplastic Agents, Phytogenic Taxane Prostatic Neoplasms |
Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Lenalidomide Urogenital Neoplasms Antimitotic Agents Genital Diseases, Male |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Prostatic Neoplasms |