A Randomized Phase III Trial of Marimastat Versus Placebo in Patients With Metastatic Breast Cancer Who Have Responding or Stable Disease After Induction Chemotherapy
OBJECTIVES: I. Determine whether marimastat prolongs progression-free survival in women with
metastatic breast cancer who have responding or stable disease after receiving standard
systemic chemotherapy. II. Determine the toxic effects of marimastat compared with placebo
in patients with metastatic breast cancer who have responding or stable disease after
receiving standard systemic chemotherapy. III. Determine whether there is an association
between trough marimastat concentration and time to disease progression and toxicity.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
stratified by the number of involved disease sites at study entry, prior chemotherapy for
metastases, osseous disease only at study entry, and bisphosphonate therapy at study entry,
and concurrent hormonal therapy (yes vs no). Patients are randomized into two groups.
Patients take either marimastat or placebo, one capsule orally twice a day, approximately
every 12 hours (i.e., during or after breakfast and dinner). The drug or placebo is given
until the development of progressive disease or prohibitive toxicity.
PROJECTED ACCRUAL: A total of 334 patients will be accrued for this study over 2 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Joseph A. Sparano, MD
Study Chair
Albert Einstein College of Medicine of Yeshiva University
United States: Food and Drug Administration
CDR0000065585
NCT00003010
September 1997
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
St. Francis Medical Center | Trenton, New Jersey 08629 |
CCOP - Columbus | Columbus, Ohio 43206 |
Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Riverview Medical Center | Red Bank, New Jersey 07701 |
Medcenter One Health System | Bismarck, North Dakota 58501 |