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Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer

OBJECTIVES: I. Determine the objective response rate to irinotecan in patients with
metastatic breast cancer who have received prior anthracycline and taxane based chemotherapy
for metastatic disease. II. Determine the toxicities of irinotecan in these patients. III.
Determine survival time, duration of response, and time to treatment failure in these
patients after this therapy.

OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment
repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at day 30, then every 3 months.

PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced breast cancer Must have received
anthracycline and taxane based chemotherapy for metastatic disease Measurable disease No
CNS metastases or carcinomatous meningitis Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance
status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count
greater than 1500/mm3 Hemoglobin at least 9.0 g/dL Platelet count greater than 100,000/mm3
Hepatic: Bilirubin no greater than 1.3 mg/dL SGOT no greater than 3 times upper limit of
normal (no greater than 5 times ULN if liver involvement) No Gilbert's disease Renal:
Creatinine no greater than 2.0 mg/dL Calcium at least 12.0 mg/dL Cardiovascular: No
myocardial infarction in the past 6 months No congestive heart failure requiring therapy
Other: No active or uncontrolled infection HIV negative No psychiatric disorder that would
preclude study No prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of
seizures No uncontrolled diabetes mellitus (random blood sugar at least 200 mg) No other
severe disease that would preclude study Not pregnant or nursing Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Greater than 4 weeks since prior chemotherapy No prior irinotecan or
topotecan Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior
radiotherapy No radiotherapy to greater than 30% of bone marrow Surgery: Not specified
Other: No concurrent phenytoin, phenobarbitol, or other antiepileptic prophylaxis

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

William J. Gradishar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 98B3



Start Date:

October 1999

Completion Date:

April 2000

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Stanford University Medical Center Stanford, California  94305-5408
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611