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

Study Overview
=================
Brief Summary
-----------------
To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer

Detailed Description
-----------------
This is a nonrandomized, open-label, phase II study of irinotecan plus capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. Up to 44 qualified patients will be enrolled according to the exact single stage design. Irinotecan 90 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period). For practical reasons, capecitabine doses are rounded to the nearest dose that could be administered with a combination of 500-mg and 150-mg tablets of drug. Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).

Official Title
-----------------
Phase II Study of Irinotecan Plus Capecitabine in Patients With Antracycline and Taxane Pretreated Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer Metastatic

Intervention / Treatment
-----------------
* Drug: Irinotecan plus capecitabine


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Irinotecan plus capecitabine<br>Irinotecan 80 mg/m2 (intravenously once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period) Capecitabine (orally at a dose of 1,000 mg/m2 twice daily 3-week cycles (2 weeks of treatment followed by a 1-week rest period)) | Drug: Irinotecan plus capecitabine<br>* Irinotecan 80 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period).<br>* Other names: Xeloda;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer |  | 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the toxicity profiles of capecitabine and irinotecan combination To determine time to progression and overall survival |  | 2009 |