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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00631527 |
Purpose
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 Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Leuprolide Drug: Goserelin Drug: Sunitinib Malate Drug: Casodex Radiation: Radiation Therapy (RT) |
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 |
|---|---|
|
Sunitinib Malate, Hormone Ablation + RT: Experimental
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
|
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
Starting dose of 12.5 mg by mouth daily for 4 weeks
Drug: Casodex
Once a day by mouth for 2 weeks.
Radiation: Radiation Therapy (RT)
Radiation treatment once daily over a period of 8 weeks.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paul Corn, MD, PHD | 713-792-2830 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Paul Corn, MD, PHD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Paul Corn, MD, PHD/Assistant Professor ) |
| Study ID Numbers: | 2006-0684 |
| Study First Received: | February 27, 2008 |
| Last Updated: | May 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00631527 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Prostate Cancer Radiation Therapy RT Radiotherapy Hormone Ablation Sunitinib Malate Leuprolide Lupron |
Zoladex Goserelin Casodex Bicalutamide SU011248 Sutent Angiogenesis inhibitor |
|
Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Neoplasms by Site Sunitinib Leuprolide Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Antineoplastic Agents, Hormonal Growth Substances Goserelin Genital Diseases, Male Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Androgen Antagonists Fertility Agents, Female Fertility Agents Bicalutamide Prostatic Neoplasms |