Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00631527
First received: February 27, 2008
Last updated: December 10, 2012
Last verified: December 2012
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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 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Drug Information available for:
Malic acid
Goserelin
Leuprolide acetate
Bicalutamide
Goserelin acetate
Sunitinib malate
Sunitinib
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT) [ Time Frame: 8 week period of combined hormone ablation, Sunitinib, and radiation therapy ] [ Designated as safety issue: Yes ]
| 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 |
Criteria
Inclusion Criteria:
- Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA > 20ng/ml.
- Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
- ECOG Performance Status 0-1
- Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x UNL, Total bilirubin WNL.
- No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
- Patients must be at least 18 years of age
- Patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.
Exclusion Criteria:
- Prior VEGFR/PDGFR inhibitor or other investigational therapy.
- Inability to take oral medication
- Chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be established with home BP readings. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Sunitinib.
- Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
- Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631527
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
| Principal Investigator: | Paul Corn, MD, PHD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided by M.D. Anderson Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Prostate Cancer Radiation Therapy RT Radiotherapy Hormone Ablation Sunitinib Malate Leuprolide Lupron |
Zoladex Goserelin Casodex Bicalutamide SU011248 Sutent Angiogenesis inhibitor |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013