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Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases Clinical research trials and Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases. Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases clinical trial. Participants frequently obtain the most expert healthcare available for their Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases  Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
For Condition: bone metastases,recurrent prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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. Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independentprostate cancer and bone metastases. PURPOSE: Randomizedphase II trial to compare the effectiveness of docetaxel with or without imatinib mesylate in treating patients who have androgen-independent prostate cancer and bone metastases.
Details: 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 144 patients (72 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 - 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 - AST and 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherLogothetis, , M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Paul Mathew 713-792-2830
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Michael Morris 646-422-4469
Additional Information:
Study ID Numbers: CDR0000354505; MDA-ID-030008,NOVARTIS-MDA-ID-030008,MSKCC-03132
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080678
Other Bone Metastases Studies:
1. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
2. Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer
3. Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases
4. Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer
5. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other bone metastases Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
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