Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00005810
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
- Detailed Description
OBJECTIVES: I. Determine the response rate (objective and PSA response) and duration of response to estramustine, docetaxel, and carboplatin with filgrastim (G-CSF) support in patients with hormone refractory prostate cancer. II. Determine the toxicity of this regimen in this patient population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Estramustine + docetaxel + carboplatin+ filgrastim filgrastim Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years. Estramustine + docetaxel + carboplatin+ filgrastim estramustine phosphate sodium Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years. Estramustine + docetaxel + carboplatin+ filgrastim docetaxel Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years. Estramustine + docetaxel + carboplatin+ filgrastim carboplatin Patients receive oral estramustine 3 times daily on days 1-5. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF) SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for a maximum of 2 years.
- Primary Outcome Measures
Name Time Method Response rate Up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States