Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00080678
First received: April 7, 2004
Last updated: October 10, 2012
Last verified: October 2012

April 7, 2004
October 10, 2012
May 2003
August 2005   (final data collection date for primary outcome measure)
Time to progression [ Time Frame: Baseline to 3 years, or until disease progression ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00080678 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Toxic effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases

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.

OBJECTIVES:

Primary

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

Secondary

  • 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Metastatic Cancer
  • Prostate Cancer
  • Drug: Docetaxel
    Other Name: taxotere
  • Drug: Imatinib Mesylate
    Other Names:
    • Imatinib
    • Gleevec
    • STI571
    • NSC-716051
  • 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.
    Interventions:
    • Drug: Docetaxel
    • Drug: Imatinib Mesylate
  • 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.
    Intervention: Drug: Docetaxel
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
March 2008
August 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • At least 3 months

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine clearance ≥ 40 mL/min

Cardiovascular

  • 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

Pulmonary

  • No oxygen-dependent lung disease

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

  • Fully recovered from prior surgery

Other

  • No concurrent ketoconazole
  • No concurrent warfarin
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00080678
CDR0000354505, MDA-ID-030008, NOVARTIS-MDA-ID-030008, MSKCC-03132, DFCI-03187
No
M.D. Anderson Cancer Center
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
M.D. Anderson Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP