|
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Subjects frequently get the best healthcare possible for their Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy  Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastaticprostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin. - Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen. - Determine the safety and toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Metastatic disease with progression despite androgen ablation (orchiectomy or luteinizing hormone-releasing hormone [LHRH] analogues) - Patients who have not undergone orchiectomy should continue LHRH analogues (e.g., leuprolide or goserelin) - Patients receiving LHRH analogues must have testosterone level less than 50 ng/dL - Disease progression defined as one of the following: - Progressive bidimensionally measurable disease independent of changes in PSA, bone scan, or performance status within past 30 days - At least 1 new lesion on bone scan within past 30 days and PSA at least 5 ng/mL - Patients with bidimensionally measurable disease or bone metastases that are not progressive but who have a rising PSA (2 successive increases over at least 2 weeks) are eligible, provided pre-entry PSA is greater than 5 ng/mL NOTE: Patients with elevated PSA as only evidence of disease are not eligible - No decreasing PSA levels after antiandrogen withdrawal - No carcinomatous meningitis or brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - AST or ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 2.5 mg/dL Cardiovascular - No history of uncontrolled serious cardiac disease - No myocardial infarction within the past 6 months - No congestive heart failure - No unstable angina - No valvular disease with documented ventricular compromise - No uncontrolled hypertension - No uncontrolled arrhythmia - No clinically significant pericardial effusion Other - Fertile patients must use effective double-barrier contraception - No peripheral sensory or motor neuropathy grade 2 or greater - No other prior or concurrent malignancies except in situ carcinoma of any site, nonmelanoma skin cancer, or other malignancy treated with surgery or radiotherapy with a disease-free survival longer than 5 years - No active serious infections - No other serious underlying medical conditions that would preclude study - No dementia or significantly altered mental status that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy or immunotherapy Chemotherapy - No prior chemotherapy for prostate cancer - 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 - No concurrent hormonal therapy (including megestrol) - No concurrent anticancer hormonal therapy - No concurrent steroids Radiotherapy - At least 4 weeks since prior radiotherapy - No prior strontium chloride Sr 89 or other radioisotopes - No concurrent radiotherapy Surgery - See Disease Characteristics - More than 3 weeks since prior major surgery (excluding biopsy or venous access device placement) and recovered Other - No other concurrent investigational therapy - No concurrent alternative or herbal therapies (including PC-SPES)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FairoozKabbinavar, Principal Investigator, David Geffen School of Medicine
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-7187
United States
Recruiting Fairooz Kabbinavar 310-206-0868
Additional Information:
Study ID Numbers: CDR0000258050; BMS-UCLA-020209201,UCLA-0202092,NCI-G02-2121
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049257
Other Stage 4 Prostate Cancer Studies:
1. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
2. Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
3. Brachytherapy in Treating Patients With Recurrent Prostate Cancer
4. Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
5. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
|
|
|
|
|
|
|
|
