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Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 11, 2004
Last Update Posted: October 26, 2012
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.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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. Giving docetaxel with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel with imatinib mesylate works in treating patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008.

Condition Intervention Phase
Metastatic Cancer Prostate Cancer Drug: Docetaxel Drug: Imatinib mesylate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Treatment efficacy [ Time Frame: 12 weeks after initiation of crossover therapy ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: From registration to disease progression, up to 32 months ]
    Time of progression was defined as the time of appearance of symptoms attributable to disease progression, the first demonstrated clinical sign or radiological evidence of disease progression, or the time of first of consecutive prostate-specific antigen (PSA) increments that achieved 25% increase over baseline or nadir (or death during the study), whichever was earliest.

  • Response rate [ Time Frame: Up to 3 years ]

Enrollment: 23
Study Start Date: May 2003
Study Completion Date: June 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel + Imatinib Mesylate
Docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-42. Courses repeat every 42 days.
Drug: Docetaxel
30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 days
Drug: Imatinib mesylate
600 mg orally daily

Detailed Description:



  • Provide treatment with docetaxel and imatinib mesylate for patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and placebo on MDA-ID-030008.


  • Determine the response rate and time to progression in these patients after crossover from docetaxel and placebo to docetaxel and imatinib mesylate.
  • Compare the modulation of the platelet-derived growth factor receptor pathway by docetaxel and imatinib mesylate vs docetaxel and placebo in the same patient.
  • Determine the quality of life of patients treated with this crossover regimen.

OUTLINE: This is an open-label, crossover, multicenter, extension study. Patients who progressed on the placebo and docetaxel arm of MDA-ID-030008 crossover to receive docetaxel and imatinib mesylate.

Patients receive docetaxel IV over 1 hour on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each therapy course, and at the completion of therapy.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 9 months.


Information from the National Library of Medicine

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, Learn About Clinical Studies.

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


  • Diagnosis of adenocarcinoma of the prostate

    • Osseous metastases
  • Androgen-independent disease
  • Previously randomized to the docetaxel and placebo arm of protocol MDA-ID-030008 and has been removed from protocol due to disease progression

    • No more than 6 weeks since final treatment with docetaxel and placebo
  • No uncontrolled brain metastases or spinal cord compression



  • Any age

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-3

Life expectancy

  • Not specified


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3


  • Bilirubin ≤ 1.5 mg/dL
  • alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 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 uncontrolled severe hypertension
  • No myocardial infarction within the past 6 months


  • No oxygen-dependent lung disease


  • No prior dose-limiting toxicity with docetaxel requiring more than 2 dose reductions
  • No severe hypersensitivity to docetaxel
  • No prior dose-limiting toxicity with docetaxel requiring 1 dose reduction AND experienced recurrent grade 3 or 4 toxicity at the time of progression on MDA-ID-030008
  • No uncontrolled diabetes mellitus
  • No concurrent severe infection
  • No overt psychosis, mental disability, or other incompetency that would preclude giving informed consent
  • No history of non-compliance
  • HIV negative
  • Fertile patients must use effective contraception


Biologic therapy

  • No concurrent biologic therapy


  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent second-line hormonal therapy


  • At least 3 weeks since prior radiotherapy
  • No recent strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium


  • Recovered from prior surgery


  • No other concurrent anticancer agents
  • No other concurrent investigational agents
  • No concurrent therapeutic warfarin

    • Concurrent mini-dose warfarin (1 mg/day) for central venous catheter prophylaxis allowed
  • No concurrent grapefruit or grapefruit juice
  Contacts and Locations
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): NCT00084825

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
  More Information

Additional Information:
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
ClinicalTrials.gov Identifier: NCT00084825     History of Changes
Other Study ID Numbers: CDR0000365625
ID03-0222 ( Other Identifier: UT MD Anderson Cancer Center )
First Submitted: June 10, 2004
First Posted: June 11, 2004
Last Update Posted: October 26, 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