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Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer Clinical research trials and Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer  Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
For Condition: Quality of Life,recurrent prostate cancer,adenocarcinoma of the prostate,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): St. Barnabas Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than once drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: I. Determine the response rate (PSA and/or objective response) and duration of response to weekly paclitaxel plus estramustine in patients with metastatic hormone refractory prostate cancer. II. Determine the effect on quality of life of this regimen in these patients. PROTOCOL OUTLINE: Patients receive paclitaxel IV over 1 hour weekly for 4 weeks. Patients receive oral estramustine the day before, the day of, and the day after paclitaxel administration each week. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. A quality of life questionnaire is completed before treatment and 2 months after treatment initiation. PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven metastatic (D1 or D2) hormone refractory adenocarcinoma of the prostate with one of the following: -Bidimensionally measurable disease; -Bone only metastases with rising PSA levels; -PSA only disease defined as rising PSA levels with prior confirmation of D1 or D2 disease - PSA must be greater than 8 if bone only or PSA only disease - Hormone failure defined as progression after treatment with orchiectomy, LHRH agonist, DES alone, or any hormonal treatment in combination with antiandrogen therapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy; No prior estramustine alone or in combination with other chemotherapy; No prior taxanes; No more than 1 prior chemotherapy regimen - Endocrine therapy: Concurrent primary hormonal therapy allowed (LHRH agonist or orchiectomy); At least 4 weeks since prior antiandrogen therapy with at least 2 rises in PSA levels - Radiotherapy: At least 4 weeks since prior radiotherapy; At least 8 weeks since prior strontium-89 therapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Not specified - Performance status: Zubrod 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte 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 no greater than 2 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Other: No other active malignancies within the past 5 years except nonmelanomatous skin cancer or other in situ cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StuartLeitner, Study Chair, St. Barnabas Medical Center
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740
United States
Additional Information:
Study ID Numbers: CDR0000066826; STBARN-IND-53879,NCI-V98-1509
Study Start Date: October 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003717
Other Quality Of Life Studies:
1. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
2. Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
3. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
4. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
5. Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
Related Studies:
Other Quality of Life Clinical Trials
Other New Jersey Clinical Trials
Other Livingston Clinical Trials
Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
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