- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003717
Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
A Phase II Trial of Weekly Paclitaxel Plus Oral Estramustine in Patients With Hormone Refractory Prostate Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Jersey
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Livingston, New Jersey, United States, 07039
- St. Barnabas Medical Center
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Long Branch, New Jersey, United States, 07740
- Monmouth Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stuart P. Leitner, MD, St. Barnabas Medical Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Estramustine
Other Study ID Numbers
- CDR0000066826
- STBARN-IND-53879
- NCI-V98-1509
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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