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

NCT00500110 | Completed Phase 2 Results

• 1 other identifier: ID03-0112
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Hormonal Ablation; Docetaxel; Imatinib Mesylate; STI571; Gleevec; Taxotere; Goserelin Acetate; Zoladex; Leuprolide; Lupron

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Pathological Complete Response

  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.

  Every 3 months for 1 year, then every 6 months until disease progression or death

Study Arms (1)

Hormonal Ablation, Imatinib + Docetaxel

EXPERIMENTAL

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; Drug: Imatinib Mesylate; Drug: Leuprolide; Drug: Goserelin Acetate

Interventions

Docetaxel DRUG

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.

Also known as: Taxotere

Hormonal Ablation, Imatinib + Docetaxel

Imatinib Mesylate DRUG

600 mg by mouth (PO) Daily x 42 Days.

Also known as: Gleevec, STI571

Hormonal Ablation, Imatinib + Docetaxel

Leuprolide DRUG

Hormone injections given every other month or every 3 months, as determined by the doctor.

Also known as: Lupron

Hormonal Ablation, Imatinib + Docetaxel

Goserelin Acetate DRUG

Hormone injections given every other month or every 3 months, as determined by the doctor.

Also known as: Zoladex

Hormonal Ablation, Imatinib + Docetaxel

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Mathew P, Pisters LL, Wood CG, Papadopoulos JN, Williams DL, Thall PF, Wen S, Horne E, Oborn CJ, Langley R, Fidler IJ, Pettaway CA. Neoadjuvant platelet derived growth factor receptor inhibitor therapy combined with docetaxel and androgen ablation for high risk localized prostate cancer. J Urol. 2009 Jan;181(1):81-7; discussion 87. doi: 10.1016/j.juro.2008.09.006. Epub 2008 Nov 13.

  PMID: 19012911 RESULT

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Imatinib Mesylate; Leuprolide; Goserelin

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; 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

Results Point of Contact

• Title: Quality Assurance Specialist
• Organization: MD Anderson Cancer Center

caperez@mdanderson.org

713-563-1602

Study Officials

• Paul Mathew, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: June 1, 2003
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 28, 2015
• Results First Posted: August 4, 2011

Record last verified: 2012-08

Locations

US (1)