Clinical trial · Interventional
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
Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
NCT00084825CI-TRIAL-00008350completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel + Imatinib Mesylate
- description
- 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.
- interventionNames
- Drug: Docetaxel
- Drug: Imatinib mesylate
Primary outcomes (1)
- measure
- Treatment efficacy
- timeFrame
- 12 weeks after initiation of crossover therapy
Secondary outcomes (2)
- measure
- Time to progression
- timeFrame
- From registration to disease progression, up to 32 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (1)
- RESULTMathew 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.