Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Camptothecin; Capecitabine; Irinotecan; Taxane

Criteria

Inclusion Criteria:

• Histologic or cytologic diagnosis of breast cancer Stage IV or recurrent.

• Previous chemotherapy with anthracyclines and taxane in adjuvant setting

• Previous hormonal therapy in adjuvant and metastatic setting is allowed

• Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.

• No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.

• Performance status of 0, 1, 2 on the ECOG criteria.

• Clinically measurable disease, defined as uni-dimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm, as defined by x-ray, CT scan, MRI, or physical examination.

• Estimated life expectancy of at least 12 weeks.

• Patient compliance that allow adequate follow-up.

• Adequate hematologic (WBC count ³ 3,000/mm3, platelet count ³ 100,000/mm3), hepatic (bilirubin level £ 1.5 mg/dL), and renal (creatinine concentration £ 1.5 mg/dL) function.

• Informed consent from patient or patient's relative.

• Males or females at least 18 years of age.

• If female: childbearing women should use non-hormonal contraceptive method

Exclusion Criteria:

• MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia.

• Serious concomitant infection.

• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).