Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080678
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : October 12, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independent prostate cancer and bone metastases.

PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see how well they work compared to docetaxel alone in treating patients with androgen-independent prostate cancer and bone metastases.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Prostate Cancer Drug: Docetaxel Drug: Imatinib Mesylate Phase 2

Detailed Description:



  • Compare time to progression in patients with androgen-independent prostate cancer and bone metastases treated with docetaxel with vs without imatinib mesylate.


  • Compare the response rates in patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to hemoglobin (< 11g/dL vs ≥ 11 g/dL), alkaline phosphatase (normal vs elevated), number of prior regimens (0 vs 1 or 2), and ECOG performance score (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-43.
  • Arm II: Patients receive docetaxel as in arm I and oral placebo once daily on days 1-43.

In both arms, courses repeat every 43 days in the absence of disease progression or unacceptable toxicity. Patients who progress on arm II may cross over to arm I.

PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases
Study Start Date : May 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Docetaxel + Imatinib Mesylate
Docetaxel 30 mg/m^2 intravenous over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral 600 mg imatinib mesylate.
Drug: Docetaxel
Other Name: taxotere

Drug: Imatinib Mesylate
Other Names:
  • Imatinib
  • Gleevec
  • STI571
  • NSC-716051

Placebo Comparator: Docetaxel + Placebo
Docetaxel 30 mg/m^2 intravenous (IV) over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral placebo.
Drug: Docetaxel
Other Name: taxotere

Primary Outcome Measures :
  1. Time to progression [ Time Frame: Baseline to 3 years, or until disease progression ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: Up to 3 years ]
  2. Toxic effects [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of adenocarcinoma of the prostate

    • Osseous metastases confirmed by radiography
    • Lytic bone lesions considered for biopsy if there is clinical suspicion of histologic conversion to small cell carcinoma
  • Failed prior hormonal therapy
  • Progressive disease, as evidenced by one of the following:

    • 2 consecutive rises in prostate-specific antigen (PSA) of at least 1 ng/mL over 4 weeks
    • Increase of 25% of the product of bidimensional disease or 30% in maximum diameter
    • Increase in number of osseous metastases by bone scan
    • Worsening symptoms attributable to disease progression (e.g., worsening bony pain)
  • PSA ≥ 1 ng/mL
  • Castrate serum testosterone ≤ 50 ng/dL

    • Concurrent luteinizing-hormone releasing-hormone analog required for medically castrated patients
  • No small cell or sarcomatoid prostate cancers
  • No uncontrolled CNS metastases



  • Any age

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • At least 3 months


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 mg/dL
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 2 times upper limit of normal
  • No chronic liver disease


  • Creatinine clearance ≥ 40 mL/min


  • No New York Heart Association class III or IV congestive heart failure
  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No evidence of myocardial ischemia on electrocardiogram
  • No uncontrolled severe hypertension


  • No oxygen-dependent lung disease


  • HIV negative
  • No concurrent severe infection
  • No contraindication to corticosteroids
  • No uncontrolled diabetes mellitus
  • No grade 2 or greater peripheral neuropathy
  • No other malignancy within the past 2 years except nonmelanoma skin cancer
  • No overt psychosis, mental disability, or incompetency that would preclude giving informed consent
  • No history of noncompliance


Biologic therapy

  • No concurrent immunotherapy


  • No prior taxanes
  • No more than 2 prior chemotherapy regimens
  • At least 30 days since prior chemotherapy and recovered
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide or nilutamide*
  • At least 6 weeks since prior bicalutamide* NOTE: *Unless there is evidence of interim disease progression


  • At least 90 days since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium and recovered
  • At least 30 days since other prior radiotherapy and recovered


  • Fully recovered from prior surgery


  • No concurrent ketoconazole
  • No concurrent warfarin

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 identifier (NCT number): NCT00080678

United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Paul Mathew M.D. Anderson Cancer Center
Study Chair: Christopher Logothetis, MD M.D. Anderson Cancer Center

Publications of Results:
Mathew P, Thall PF, Johnson MM, et al.: Preliminary results of a randomized placebo-controlled double-blind trial of weekly docetaxel combined with imatinib in men with metastatic androgen-independent prostate cancer (AIPC) and bone metastases (BM). [Abstract] J Clin Oncol 24 (Suppl 18): A-4562, 232s, 2006.

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00080678     History of Changes
Other Study ID Numbers: CDR0000354505
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012

Keywords provided by M.D. Anderson Cancer Center:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
bone metastases

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs