Irinotecan in Treating Patients With Metastatic or Recurrent Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004182
• Other study ID #: NU 98B3
• Secondary ID: NU-98B3P-UPJOHN-
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2000
• Last updated: May 31, 2012
• Start date: October 1999
• Est. completion date: April 2000

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2000
• Est. primary completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,