|
DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer 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 DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer Clinical research trials and DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer 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 DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer. DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer 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 DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer 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.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer  DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 4 prostate cancer,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel. - Determine the overall survival of patients treated with this drug. - Determine the toxicity profile of this drug in these patients. - Assess the quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and off study. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-50 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 or cytologically confirmed adenocarcinoma of the prostate - Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist) - Progressive disease is defined by all of the following: - Measurable disease or lesions on bone scan - Increases in prostate-specific antigen (PSA) levels on at least 2 consecutive measurements - Continued PSA elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide) - PSA level at least 5 ng/mL - Serum testosterone level less than 50 ng/mL - Patients who have not undergone prior surgical castration should continue primary androgen suppression (LHRH agonist) - No known or clinical evidence of CNS metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled ventricular arrhythmia - No myocardial infarction within the past 3 months - No superior vena cava syndrome Neurologic: - No peripheral neuropathy greater than grade 1 - No uncontrolled major seizure disorder - No spinal cord compression Other: - No psychiatric disorder that would preclude informed consent - No unstable or serious concurrent medical condition - No concurrent serious infection requiring parenteral therapy - No other prior or concurrent malignancy except: - Curatively treated nonmelanoma skin cancer OR - Other cancer curatively treated with surgery alone that has not recurred for more than 5 years - Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy Chemotherapy: - No prior taxanes - Prior mitoxantrone or prednisone for metastatic disease allowed - At least 28 days since prior chemotherapy and recovered - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - No concurrent hormonal therapy Radiotherapy: - No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89 - Prior external radiotherapy for metastatic disease allowed - At least 28 days since prior large-field radiotherapy and recovered - No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS metastasis Surgery: - See Disease Characteristics - At least 14 days since prior major surgery and recovered Other: - No other prior nonhormonal treatment for metastatic disease - At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered - No other concurrent anticancer medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelCarducci, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0098
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Arizona Oncology Associates
Tucson, Arizona, 85712-2254
United States
Additional Information:
Study ID Numbers: CDR0000068930; JHOC-01011003,THERADEX-P01-00-04,PROTARGA-P01-00-04
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024414
Other Recurrent Prostate Cancer Studies:
1. Hormone Therapy in Treating Men With Stage IV Prostate Cancer
2. Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
3. Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
4. Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients with Locally Advanced Prostate Cancer
5. Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Kentucky Clinical Trials
Other Lexington Clinical Trials
DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
|
|
|
|
|
|
|
|
