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Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00003717

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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estramustine phosphate sodium

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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St. Barnabas Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Stuart P. Leitner, MD

Role: STUDY_CHAIR

St. Barnabas Medical Center

Locations

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St. Barnabas Medical Center

Livingston, New Jersey, United States

Site Status

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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STBARN-IND-53879

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1509

Identifier Type: -

Identifier Source: secondary_id

CDR0000066826

Identifier Type: -

Identifier Source: org_study_id