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Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Registration Number
NCT00003351
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

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

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of irinotecan in treating patients who have refractory metastatic breast cancer.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
104
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm I: irinotecanirinotecan hydrochloridePatients 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. Quality of life is assessed before and during treatment. Patients are followed every 3 months for 2 years, then annually for 1 year.
Arm II: irinotecanirinotecan hydrochloridePatients 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.
Primary Outcome Measures
NameTimeMethod
Time to progressionUp to 3 years
Secondary Outcome Measures
NameTimeMethod
Quality of lifeUp to 3 years
SurvivalUp to 3 years

Trial Locations

Locations (22)

CCOP - Scottsdale Oncology Program

🇺🇸

Scottsdale, Arizona, United States

CCOP - Illinois Oncology Research Association

🇺🇸

Peoria, Illinois, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

🇺🇸

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

🇺🇸

Des Moines, Iowa, United States

Siouxland Hematology-Oncology

🇺🇸

Sioux City, Iowa, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

CCOP - Ochsner

🇺🇸

New Orleans, Louisiana, United States

CCOP - Ann Arbor Regional

🇺🇸

Ann Arbor, Michigan, United States

CCOP - Duluth

🇺🇸

Duluth, Minnesota, United States

Scroll for more (12 remaining)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States

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