A Phase 1 interventional study of Leuprolide and Goserelin in Prostate Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-29.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
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.
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.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to a study group. 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 or goserelin. 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 may also receive bicalutamide. This will be left up to the doctor. 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 every 6 months via telephone call and/or a review of your medical record. If contacted, you will be asked about any side effects you have had, or therapies you may have had since stopping treatment on this study. You will be followed for up to 10 years once you have taken sunitinib malate for 20 weeks.
This is an investigational study. Sunitinib malate is FDA approved and commercially available for the treatment of adults with kidney cancer.
Bicalutamide, leuprolide, and goserelin are FDA approved and commercially available for use in prostate cancer.
Up to 22 patients will be enrolled in this multicenter trial. Up to 12 will be enrolled at MD Anderson.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 19 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
Drug: Leuprolide · Drug: Goserelin · Drug: Sunitinib Malate · Drug: Casodex · Radiation: Radiation Therapy (RT)
Injections given through a needle in the muscle every 3 months.
Also known as: Lupron
Subcutaneous injections given once every 3 months.
Also known as: Zoladex
Starting dose of 12.5 mg by mouth daily for 4 weeks
Also known as: SU011248, Sutent
Once a day by mouth for 2 weeks.
Also known as: Bicalutamide
Radiation treatment once daily over a period of 8 weeks.
Also known as: Radiotherapy
Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT)
DLT defined as inability to complete the schedule course of radiation therapy for toxicity of any grade. If \< 2 patients in initial cohort of 6 experience DLT then a subsequent dose-level cohort initiated. If 2 or more patients in a cohort experience DLT then further accrual to that cohort curtailed and no higher dose level examined. Maximum tolerated dose (MTD) for oral sunitinib in combination with radiation and hormone ablation defined as highest dose level in which 6 patients have been treated with 2 or less than 2 instances of DLT. DLT for the purposes of dose-escalation or calculation of the maximum tolerated dose (MTD) defined as any medically unmanageable Grade 2 toxicity or any Grade 3 or 4 toxicity experienced during the 8 week period of combined hormone ablation, Sunitinib, and radiation therapy.
Time frame: 8 weeks
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center