Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
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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:
- To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer.
- 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:
Drug Information available for:
Goserelin
Leuprolide acetate
Docetaxel
Goserelin acetate
Imatinib
Imatinib mesylate
U.S. FDA Resources
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:
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
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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Leuprolide Goserelin Docetaxel Imatinib |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013