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Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00631527
First received: February 27, 2008
Last updated: December 11, 2013
Last verified: December 2013
  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:


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 2015 (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:
  • SU011248
  • Sutent
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:

  1. 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.
  2. 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.
  3. ECOG Performance Status 0-1
  4. 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.
  5. No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
  6. Patients must be at least 18 years of age
  7. 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:

  1. Prior VEGFR/PDGFR inhibitor or other investigational therapy.
  2. Inability to take oral medication
  3. 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.
  4. 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.
  5. Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 11, 2013
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Goserelin
Hormones
Leuprolide
Sunitinib
Androgen Antagonists
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Growth Inhibitors
Growth Substances
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014