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
OBJECTIVES:
- 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
patients.
- 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
these patients.
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
mitoxantrone.
- 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
annually thereafter.
PROJECTED ACCRUAL: A total of 70-114 patients (35-57 per arm) will be accrued for this study
within 14-23 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Robert S. DiPaola, MD
Study Chair
Cancer Institute of New Jersey
United States: Food and Drug Administration
CDR0000067865
NCT00005847
January 2001
Name | Location |
---|---|
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 |