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:
M.D. Anderson Cancer Center
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
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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
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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013