Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Study of Weekly Paclitaxel by 1-HR Infusion Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003614
• Other study ID #: CDR0000066691
• Secondary ID: E-1898
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 1999

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• estramustine phosphate sodium

• paclitaxel

Locations

Country	Name	City	State
South Africa	Pretoria Academic Hospital	Pretoria
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois
United States	Ireland Cancer Center	Cleveland	Ohio
United States	CCOP - Geisinger Clinical and Medical Center	Danville	Pennsylvania
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Indiana University Hospitals	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Rochester Cancer Center	Rochester	New York
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (1)

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. [Abst