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Status:

COMPLETED

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

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Metastatic Cancer

Prostate Cancer

Eligibility:

MALE

Phase:

PHASE2

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 ...

Detailed Description

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 * Co...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2008

    Estimated Enrollment :

    116 Patients enrolled

    Trial Details

    Trial ID

    NCT00080678

    Start Date

    May 1 2003

    End Date

    March 1 2008

    Last Update

    October 12 2012

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    2

    Memorial Sloan-Kettering Cancer Center

    New York, New York, United States, 10021

    3

    M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009