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Randomized Phase II Trial of Irinotecan (CPT-11) In Patients With Refractory Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Randomized Phase II Trial of Irinotecan (CPT-11) In Patients With Refractory Metastatic Breast Cancer

OBJECTIVES: I. Assess the antitumor activity and toxicity of two different schedules of
irinotecan in the treatment of patients with refractory metastatic breast cancer who have
received 1 or 2 previous chemotherapy regimens (up to one prior therapy for metastatic
disease and one for adjuvant therapy). II. Compare the time to progression, survival, and
quality of life of these patients on these 2 different schedules of irinotecan.

OUTLINE: This is a randomized study. Patients are stratified according to dominant disease
(visceral vs nonvisceral), performance status (0-1 vs 2), and prior chemotherapy in
metastatic setting (yes vs no). Patients assigned to arm I receive irinotecan intravenously
over 90 minutes every week for 4 weeks followed by a 2 week rest period. Treatment is
repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients assigned to arm II receive irinotecan intravenously over 90 minutes every 3 weeks
for 6 weeks. Treatment is repeated every 6 weeks in the absence of disease progression or
unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are
followed every 3 months for 2 years, then annually for 1 year.

PROJECTED ACCRUAL: A total of 42-100 patients (21-50 patients per arm) will be accrued for
this study within 3.5 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast with
progressing locoregional or metastatic disease Measurable or evaluable indicator lesion No
uncontrolled CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 0.3 mg/dL above upper limit
of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 1.0
mg/dL above ULN Cardiovascular: No New York Heart Association class III or IV heart
disease Other: No uncontrolled infection No chronic debilitating disease Not pregnant or
lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since chemotherapy No more than 2 prior chemotherapy regimens for metastatic disease No
more than 1 prior chemotherapy regimen in the adjuvant setting At least 1 prior regimen
containing taxane or doxorubicin for metastatic disease or in the adjuvant setting
Endocrine therapy: Not specified Radiotherapy: No radiotherapy to greater than 25% of bone
marrow No prior treatment with strontium 89 Surgery: At least 4 weeks since major surgery
Other: No concurrent metoclopramide

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • Breast Neoplasms



Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
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
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
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
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Medcenter One Health SystemBismarck, North Dakota  58501