Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer.

Detailed Description
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OBJECTIVES: Primary Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer. Secondary Determine the toxicity profile of this regimen in these patients. Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 2 months until disease progression and then every 6 months thereafter.

Official Title
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Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease At least one unidimensionally measurable lesion At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are allowed Lesions on chest x-ray are allowed provided they are clearly defined and surrounded by aerated lung The following are not considered measurable: Bone lesions Ascites Leptomeningeal disease Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Cystic lesions No known CNS metastases unless controlled by prior surgery and/or radiotherapy Hormone receptor status: Estrogen receptor (ER) and/or progesterone receptor (PR) status known PATIENT CHARACTERISTICS: Age 18 and over Sex Male or female Menopausal status Not specified Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Granulocyte count ≥ 1,500/mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ upper limit of normal (ULN) Meets 1 of the following criteria: AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Cardiovascular No myocardial infarction within the past 180 days No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmias Other No active, unresolved infection No prior severe hypersensitivity reaction to docetaxel, irinotecan, or any drug formulated with polysorbate 80 No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No grade 1 or greater sensory or motor neuropathy No other concurrent severe condition that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless contraindicated) Chemotherapy See Disease Characteristics More than 14 days since prior chemotherapy No more than 2 prior chemotherapy regimens for metastatic disease No prior irinotecan or docetaxel for metastatic disease Docetaxel as adjuvant therapy allowed No other concurrent chemotherapy Endocrine therapy Prior hormonal therapy required for patients with ER- and/or PR-positive tumors (unless contraindicated) Radiotherapy See Disease Characteristics At least 30 days since prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics At least 3 weeks since prior major surgery and recovered Other More than 7 days since prior parenteral antibiotic therapy No other concurrent experimental drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: docetaxel + irinotecan<br>Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 2 months until disease progression and then every 6 months thereafter. | Drug: docetaxel<br> <br> Drug: irinotecan hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed tumor response as measured by RECIST criteria |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of progression times |  | Up to 5 years | 
| Overall survival |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, male breast cancer