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| Tracking Information | |||||
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| First Received Date ICMJE | February 27, 2008 | ||||
| Last Updated Date | May 27, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Feasibility study of the combination of sunitinib, hormone ablation and external beam radiation in men with localized high-risk and locally advanced prostate cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
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. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00631527 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer | ||||
| Official Title ICMJE | Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer | ||||
| Brief Summary | 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:
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| Detailed Description | The Study Drugs: Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer. Luteinizing Hormone-Releasing Hormone (LHRH) Analogues like Lupron® (leuprolide) and Zoladex® (goserelin) are hormonal treatments used to help stop the body from making testosterone (male sex hormones) in the body. Prostate cancer cells need testosterone to survive. Anti-Androgen drugs, like Casodex® (bicalutamide) also stop cell growth by blocking male hormones like testosterone. Screening Tests: Before you can start receiving sunitinib malate on this study, you will have "screening tests." These tests will help the study doctor decide if you are eligible to take part in this study. Within 6 weeks before enrollment on this study, you will have the following tests and procedures performed.
Within 14 days before enrollment on this study, you will have the following tests.
Within 7 days before enrollment on this study, you will have the following tests.
Study Drug Administration: If you are found to be eligible to take part in this study, you will be assigned to a study group. Up to 3 groups of 6 participants each will be enrolled in this study. The group you are assigned to and dose of sunitinib malate you receive will depend on when you join this study. Three (3) dose levels of sunitinib malate will be tested. The first group of participants will receive the lowest dose of sunitinib malate. The next group enrolled will receive a higher dose of sunitinib malate, if no intolerable side effects were seen. Before you begin taking sunitinib, you will begin receiving hormone therapy. You will receive leuprolide and bicalutamide or goserelin and bicalutamide. Leuprolide is given through a needle in your muscle, and goserelin is given through a needle under the skin in the abdomen. You will receive 1 of these injections every 3 months. Which hormonal drug you are given (leuprolide or goserelin) will be assigned by your doctor and/or will depend on your insurance coverage. You will take bicalutamide by mouth once a day for 2 weeks (with or without food). After at least 4 weeks of hormone therapy have been given, you will begin taking sunitinib malate in combination with the hormone therapy. You will take sunitinib malate once a day (either with or without food) for 16 weeks in a row. Radiation Therapy: After 4 weeks of combined treatment with sunitinib and hormone therapy, you will begin radiation treatments. Radiation treatments will be given once a day, 5 days a week, for about 8 weeks. Each treatment will take 20-30 minutes. This procedure will be discussed with you in more detail. You will continue taking sunitinib and hormone therapy while you are on radiation treatments. Study Visits: On the day you start treatment with sunitinib, you will have the following tests and procedures performed:
About Day 15 of treatment with sunitinib, and on the day you begin radiation therapy (before your first treatment), you will have the following tests and procedures performed:
Every 2 weeks during radiation therapy, you will have the following tests and procedures performed:
About 4 weeks after you stop radiation therapy, you will have the following test and procedures performed:
Length of Study: You will continue taking sunitinib malate on this study for a total of 16 weeks. Radiation treatments will last for up to 8 weeks. Hormone injections will continue for a period of 2 years. You will be taken off this study if intolerable side effects occur or the disease gets worse. Long-Term Follow-up: You will be followed for up to 10 years once you have taken sunitinib malate for 20 weeks. You will have these tests every 12 weeks until 2 years after radiation, every 6 months until 5 years, and then yearly until 10 years. At these visits, you will be asked about any side effects you have experienced since your last visit. Blood (about 1 teaspoons) will be drawn for routine tests, including PSA and testosterone levels. At 12 and 24 months after radiation therapy, you will complete a quality-of-life survey that will have questions about how you are feeling. They should take about 10 minutes to complete. This is an investigational study. Sunitinib malate is FDA approved and commercially available for the treatment of adults with kidney cancer. Sunitinib malate will be provided free of charge while you are on this study. Bicalutamide, leuprolide, and goserelin are FDA approved and commercially available for use in prostate cancer. Up to 18 patients will be enrolled in this multicenter trial. Up to 12 will be enrolled at M.D. Anderson. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Experimental: Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT) | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 18 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00631527 | ||||
| Responsible Party | Paul Corn, MD, PHD/Assistant Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2006-0684 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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