Completed

Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases

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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

Placebo-Controlled
Phase 2
Interventional
Study Start: May 2003
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleRandomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases 
NCT00080678
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 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
116 patients to be enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Prostatic Neoplasms
Urogenital Neoplasms
Male Urogenital Diseases
Criteria

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


Study Plan

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

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
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.

Group II
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.

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 InstituteBoston, United StatesSee the location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United States
Suspended
M.D. Anderson Cancer Center at University of TexasHouston, United States

Completed3 Study Centers
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