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

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ClinicalTrials.gov Identifier: NCT00500110
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : August 4, 2011
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Imatinib Mesylate Drug: Leuprolide Drug: Goserelin Acetate Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer
Study Start Date : June 2003
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Participants Achieving Pathological Complete Response [ Time Frame: Every 3 months for 1 year, then every 6 months until disease progression or death ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500110     History of Changes
Other Study ID Numbers: ID03-0112
First Posted: July 12, 2007    Key Record Dates
Results First Posted: August 4, 2011
Last Update Posted: April 28, 2015
Last Verified: August 2012

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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Imatinib Mesylate
Leuprolide
Goserelin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal