Completed

Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008

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What is being tested

Docetaxel

+ Imatinib mesylate

Drug
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Genital Diseases, Male

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2003
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleCrossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008 
NCT00084825
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

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

Boston, United StatesSee the location
Suspended

Memorial Sloan-Kettering Cancer Center

New York, United States
Suspended

M.D. Anderson Cancer Center at University of Texas

Houston, United States
Completed3 Study Centers