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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00631527 |
Purpose
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
| 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer |
| Estimated Enrollment: | 22 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
|
Drug: Leuprolide
Injections given through a needle in the muscle every 3 months.
Other Name: Lupron
Drug: Goserelin
Subcutaneous injections given once every 3 months.
Other Name: Zoladex
Drug: Sunitinib Malate
Starting dose of 12.5 mg by mouth daily for 4 weeks
Other Names:
Drug: Casodex
Once a day by mouth for 2 weeks.
Other Name: Bicalutamide
Radiation: Radiation Therapy (RT)
Radiation treatment once daily over a period of 8 weeks.
Other Name: Radiotherapy
|
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| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Paul Corn, MD, PHD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00631527 History of Changes |
| Other Study ID Numbers: | 2006-0684 |
| Study First Received: | February 27, 2008 |
| Last Updated: | January 18, 2012 |
| 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 Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Hormones Angiogenesis Inhibitors Sunitinib Leuprolide Goserelin Bicalutamide Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Hormonal Fertility Agents, Female Fertility Agents Reproductive Control Agents Androgen Antagonists Hormone Antagonists |