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A Randomized Phase III Trial of Marimastat Versus Placebo in Patients With Metastatic Breast Cancer Who Have Responding or Stable Disease After Induction Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast with
previous manifestations of progressing regional or metastatic cancer Received one prior
systemic chemotherapy regimen for the treatment of metastases, which meets all of the
following criteria: Included either doxorubicin, a taxane (i.e., paclitaxel or docetaxel),
or both 6-8 courses were given If weekly taxane therapy received, at least 12 doses were
given Recovered from all related toxic effects (except alopecia and/or neuropathy) 3-6
weeks have elapsed since last course of chemotherapy was given No more than 40 weeks have
elapsed since the first dose of chemotherapy for metastases No current or prior history of
brain metastases Responding or stable disease since the initiation of systemic
chemotherapy (i.e., no disease progression) required No prior enrollment on ECOG trials
for metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal Status: Not specified
Performance status: ECOG 0 or 1 Hematopoietic: Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no
greater 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other:
Not pregnant or nursing Negative pregnancy test required if pre- or peri-menopausal (i.e.,
last menstrual period within one year prior to study) Pre- or peri-menopausal sexually
active women must use effective contraception No other invasive malignancy within last 5
years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma
in situ of the cervix No history of rheumatoid arthritis, osteoarthritis, symptomatic
osteoarthritis requiring therapy, or other inflammatory arthritis At least 5 years since
prior invasive malignancies except: Curatively treated basal cell or squamous cell
carcinoma of the skin Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No prior
trastuzumab Chemotherapy: See Disease Characteristics No concurrent chemotherapy No prior
marimastat or batimastat Endocrine therapy: Prior and/or concurrent hormonal therapy for
breast cancer allowed Concurrent hormonal therapy allowed Radiotherapy: No concurrent
radiotherapy Surgery: No prior organ allograft Other: At least 4 weeks since other
investigational agents No concurrent bisphosphonate therapy unless it was initiated prior
to the study No concurrent immunosuppressive therapy Patients receiving anticoagulant
therapy must be carefully monitored

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joseph A. Sparano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065585

NCT ID:

NCT00003010

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CentraCare ClinicSaint Cloud, Minnesota  56303
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
St. Francis Medical CenterTrenton, New Jersey  08629
CCOP - ColumbusColumbus, Ohio  43206
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Hackensack University Medical CenterHackensack, New Jersey  07601
Riverview Medical CenterRed Bank, New Jersey  07701
Medcenter One Health SystemBismarck, North Dakota  58501