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

NCT00631527 | Completed Phase 1

• 2 other identifiers: 2006-0684NCI-2010-01524
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Radiation Therapy; RT; Radiotherapy; Hormone Ablation; Sunitinib Malate; Leuprolide; Lupron; Zoladex; Goserelin; Casodex; Bicalutamide; SU011248; Sutent; Angiogenesis inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (1)

Sunitinib Malate, Hormone Ablation + RT

EXPERIMENTAL

Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)

Drug: Leuprolide; Drug: Goserelin; Drug: Sunitinib Malate; Drug: Casodex; Radiation: Radiation Therapy (RT)

Interventions

Leuprolide DRUG

Injections given through a needle in the muscle every 3 months.

Also known as: Lupron

Sunitinib Malate, Hormone Ablation + RT

Goserelin DRUG

Subcutaneous injections given once every 3 months.

Also known as: Zoladex

Sunitinib Malate, Hormone Ablation + RT

Sunitinib Malate DRUG

Starting dose of 12.5 mg by mouth daily for 4 weeks

Also known as: SU011248, Sutent

Sunitinib Malate, Hormone Ablation + RT

Casodex DRUG

Once a day by mouth for 2 weeks.

Also known as: Bicalutamide

Sunitinib Malate, Hormone Ablation + RT

Radiation Therapy (RT) RADIATION

Radiation treatment once daily over a period of 8 weeks.

Also known as: Radiotherapy

Sunitinib Malate, Hormone Ablation + RT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (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 upper normal limit (UNL), Total bilirubin within normal limits (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.

You may not qualify if:

• Prior VEGFR/PDGFR inhibitor or other investigational therapy.
• Inability to take oral medication
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Karlou M, Tzelepi V, Efstathiou E. Therapeutic targeting of the prostate cancer microenvironment. Nat Rev Urol. 2010 Sep;7(9):494-509. doi: 10.1038/nrurol.2010.134.

  PMID: 20818327 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; Goserelin; Sunitinib; bicalutamide; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Paul Corn, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2015
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

US (1)