Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00500110
First received: July 10, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Primary Objective:

1. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer.

Secondary Objectives:

  1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer.
  2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor Receptor (PDGFR) pathway.

Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Drug: Imatinib Mesylate
Drug: Leuprolide
Drug: Goserelin Acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants Achieving Pathological Complete Response [ Time Frame: Every 3 months for 1 year, then every 6 months until disease progression or death ] [ Designated as safety issue: No ]
    Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.


Enrollment: 39
Study Start Date: June 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hormonal Ablation, Imatinib + Docetaxel
Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Drug: Docetaxel
30 mg/m^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.
Other Name: Taxotere
Drug: Imatinib Mesylate
600 mg by mouth (PO) Daily x 42 Days.
Other Names:
  • Gleevec
  • STI571
Drug: Leuprolide
Hormone injections given every other month or every 3 months, as determined by the doctor.
Other Name: Lupron
Drug: Goserelin Acetate
Hormone injections given every other month or every 3 months, as determined by the doctor.
Other Name: Zoladex

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included.
  • All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
  • All patients must have at least one of the following high-risk features: clinical or pathological T3 disease, or cT2c or PSA>20ng/ml or Gleason 8-10 adenocarcinoma or clinical T2b and PSA>10ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.
  • Prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is permitted.
  • Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,500/mm3 and platelet count of >/= 100,000/mm3; adequate hepatic function defined with a total bilirubin of </= 1.5 mg/dl and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) </= 2 times the upper limits of normal; adequate renal function defined as serum creatinine clearance >/= 40 cc/min (measured or calculated).
  • Patients must sign a written informed consent form prior to treatment. All patients must have a surgical and medical oncology consult prior to signing informed consent.

Exclusion Criteria:

  • Patients with small cell or sarcomatoid prostate cancers are not eligible.
  • Patients with clinical or radiological evidence of metastatic disease
  • Prior chemotherapy or experimental agents
  • Patients with severe intercurrent infection.
  • Patients with The New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or myocardial infarction (MI) in the last 6 months.
  • Contraindications to corticosteroids.
  • Uncontrolled severe hypertension, uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or human immunodeficiency virus (HIV) infection.
  • Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
  • Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
  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: NCT00500110

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: Paul Mathew, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500110     History of Changes
Other Study ID Numbers: ID03-0112
Study First Received: July 10, 2007
Results First Received: July 11, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Hormonal Ablation
Docetaxel
Imatinib Mesylate
STI571
Gleevec
Taxotere
Goserelin Acetate
Zoladex
Leuprolide
Lupron

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Goserelin
Imatinib
Leuprolide
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Fertility Agents
Fertility Agents, Female
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Reproductive Control Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 30, 2014