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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Pfizer |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00631527 |
Primary Objective:
1. To define the tolerability of three different dose-levels of the angiogenesis inhibitor, sunitinib malate, in combination with hormone ablation and external beam radiation for high-risk and locally advanced prostate cancer.
Secondary:
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Leuprolide Drug: Goserelin Drug: Sunitinib Malate Drug: Bicalutamide Radiation: Radiation Therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy
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Drug: Leuprolide
Injections given through a needle in the muscle every 3 months.
Drug: Goserelin
Subcutaneous injections given once every 3 months.
Drug: Sunitinib Malate
12.5 mg PO daily for 4 weeks
Drug: Bicalutamide
PO daily for 2 weeks.
Radiation: Radiation Therapy
Radiation treatment once daily over a period of 8 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Mathew, MD | 713-792-2830 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Paul Mathew, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Paul Mathew, MD/Assistant Professor ) |
Study ID Numbers: | 2006-0684 |
Study First Received: | February 27, 2008 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00631527 |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer Radiation Therapy Hormone Ablation Sunitinib Malate Leuprolide Lupron |
Zoladex Goserelin Casodex Bicalutamide SU011248 Sutent |
Prostatic Diseases Genital Neoplasms, Male Leuprolide Sunitinib Goserelin |
Bicalutamide Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Antineoplastic Agents Growth Substances Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Fertility Agents, Female Fertility Agents Growth Inhibitors Angiogenesis Modulating Agents |