|
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult 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 site devoted 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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 volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated 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. Test subjects oftentimes receive the most effective healthcare possible for their Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous 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 Adenocarcinoma Of The Prostate Studies:
1. Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
2. Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
3. Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer
4. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
5. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate 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
|
|
|
|
|
|
|
|
