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.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00084825
First received: June 10, 2004
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: From registration to disease progression, up to 32 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-3

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Pulmonary

  • No oxygen-dependent lung disease

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy

Chemotherapy

  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent second-line hormonal therapy

Radiotherapy

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

Surgery

  • Recovered from prior surgery

Other

  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084825

Locations
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
Investigators
Study Chair: Paul Mathew M.D. Anderson Cancer Center
Study Chair: Christopher Logothetis, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
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, MDA-ID-030222, MSKCC-03149, ID03-0222
Study First Received: June 10, 2004
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

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:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Androgens
Docetaxel
Imatinib
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 15, 2014