Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00003614

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-04

Brief Summary

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 paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES: I. Determine the effect of weekly paclitaxel plus estramustine on PSA response in patients with metastatic hormone-refractory prostate cancer. II. Describe the toxic effects of this treatment in this patient population. III. Determine the effect of treatment on pain, asthenia, and quality of life. IV. Determine the objective response rate after treatment among the patients with bidimensionally measurable disease.

OUTLINE: Patients receive estramustine orally twice a day on days 1-3 of each week for 6 weeks. Patients also receive paclitaxel IV over 1 hour on day 2 of each week for 6 weeks. Courses repeat every 8 weeks in the absence of unacceptable toxicity and disease progression. Quality of life is assessed prior to treatment and at weeks 4, 8, 20, and 24. Patients are followed every 3 months for 2 years, every 6 months for years 2-5, and then annually thereafter.

PROJECTED ACCRUAL: There will be 17-52 patients accrued into this study over 14 months.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

estramustine phosphate sodium

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic hormone-refractory adenocarcinoma of the prostate gland Elevated serum acid phosphatase or PSA levels must not be only evidence of disease Must have evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver, or lung metastases) Radiological evidence of hydronephrosis alone does not constitute evidence of metastatic disease Patients with bone metastases only (i.e., lacking measurable soft tissue disease) must have PSA level of at least 20 ng/mL Patients with soft tissue metastases and/or visceral disease must have either bidimensionally measurable disease or a PSA level of at least 20 ng/mL Must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g., estrogen therapy, LHRH-blocker plus flutamide, etc.) with evidence of treatment failure 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 4,000/mm3 OR Granulocyte count at least 2,000/mm3 Platelet count greater than 100,000/mm3 No history of deep venous thrombosis Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No active angina pectoris No known New York Heart Association class II-IV heart disease No history of myocardial infarction in the last 6 months Other: No history of prior malignancy except if curatively treated and disease free for time period considered appropriate for cure of specific cancer No other serious concurrent illness or active infection Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy (including neoadjuvant chemotherapy) Endocrine therapy: See Disease Characteristics At least 6 weeks since prior bicalutamide At least 4 weeks since prior flutamide or nilutamide Recovered from prior toxicities of endocrine therapy Radiotherapy: No prior strontium 89, samarium 153, or other radioisotope therapies At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Recovered from prior surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Gary R. Hudes, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Lakeside)

Chicago, Illinois, United States

CCOP - Central Illinois

Decatur, Illinois, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Indiana University Hospitals

Indianapolis, Indiana, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

New England Medical Center Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

CCOP - Northern New Jersey

Hackensack, New Jersey, United States

University of Rochester Cancer Center

Rochester, New York, United States

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Ireland Cancer Center

Cleveland, Ohio, United States

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

CCOP - MainLine Health

Wynnewood, Pennsylvania, United States

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Pretoria Academic Hospital

Pretoria, , South Africa

Countries

United States; South Africa

References

Hudes GR, Manola J, Conroy J, et al.: Phase II study of weekly paclitaxel (P) by 1-hour infusion plus reduced-dose oral estramustine (EMP) in metastatic hormone-refractory prostate carcinoma (HRPC): a trial of the Eastern Cooperative Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-697, 2001.

Reference Type: RESULT

Other Identifiers

E-1898

Identifier Type: -

Identifier Source: secondary_id

CDR0000066691

Identifier Type: -

Identifier Source: org_study_id