A Randomized Phase II Trial of Mitoxantrone, Estramustine and Navelbine or 13-cis Retinoic Acid, Interferon and Paclitaxel in Patients With Metatstatic Hormone Refractory Prostate Cancer
- Compare the effect of estramustine, mitoxantrone, and vinorelbine vs isotretinoin,
interferon alfa, and paclitaxel on PSA response in patients with metastatic
hormone-refractory prostate cancer.
- Determine the toxic effects of each regimen in this patient population.
- Determine the effect of each regimen on pain, fatigue, and quality of life in these
- Determine the objective response rate among the subset of patients who have
bidimensionally measurable disease to each regimen after treatment.
- Determine the effect of each regimen on peripheral blood mononuclear cell BCL-2 in
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease (measurable vs nonmeasurable and elevated PSA). Patients are randomized to one of
two treatment arms.
- Arm I: Patients receive vinorelbine IV over 10 minutes on days 2 and 9 followed by
mitoxantrone IV over 10 minutes on day 2 only. Oral estramustine is administered every
12 hours on days 1-5. Courses repeat every 3 weeks in the absence of unacceptable
toxicity, disease progression, or administration of the maximum cumulative dose of
- Arm II: Patients receive oral isotretinoin and interferon alfa subcutaneously on days 1
and 2 and paclitaxel IV over 1 hour on day 2 weekly for 6 weeks. Courses repeat every 8
weeks in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, on day 2 of courses 2, 4, and 6 (arm I), on day 22
of course 1 and day 1 of courses 2 and 3 (arm II), and then at completion of treatment.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 70-114 patients (35-57 per arm) will be accrued for this study
within 14-23 months.
Allocation: Randomized, Primary Purpose: Treatment
Robert S. DiPaola, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Veterans Affairs Medical Center - Atlanta (Decatur)||Decatur, Georgia 30033|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|CCOP - Colorado Cancer Research Program, Incorporated||Denver, Colorado 80224|
|Tufts - New England Medical Center||Boston, Massachusetts 02111|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|MBCCOP-Our Lady of Mercy Cancer Center||Bronx, New York 10466|