Paclitaxel Poliglumex and Capecitabine in Treating Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with capecitabine works in treating patients with metastatic breast cancer.

Detailed Description
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OBJECTIVES: Assess the tumor response rate and adverse event profile in patients with metastatic, HER2 negative breast cancer treated with paclitaxel poliglumex (CT-2103; Xyotax™) and capecitabine. Examine the distributions of disease-free progression times and survival times in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for up to 5 years.

Official Title
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Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: paclitaxel poliglumex


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologic or cytologic confirmation of breast cancer with clinical evidence of metastatic disease No bone metastases as the only evidence of metastasis Measurable disease, defined as at least one measurable lesion No non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 2.0 cm) and truly non-measurable lesions, which include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known brain metastasis HER2 negative disease by immunohistochemistry and/or fluorescent in situ hybridization Diagnostic tissue and operative and pathology reports from breast cancer diagnosis and/or diagnosis of metastatic breast cancer must be available Hormone receptor status Not specified PATIENT CHARACTERISTICS: Males or females are eligible Menopausal status: not specified Life expectancy ≥ 3 months ECOG performance status 0 or 1 Any serum estradiol level allowed Hemoglobin > 8.0 g/dL Absolute neutrophil count ≥ 1500/mL Platelet count ≥ 100,000/mL Bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN AST and ALT ≤ 2.5 times UNL Calcium normal Creatinine clearance ≥ 30 mL/min Not pregnant or nursing Negative pregnancy test Women of childbearing potential or their sexual partners must be willing to employ adequate contraception (as determined by the treating physician) for the duration of the study and for 30 days after treatment has ended No stage III or IV invasive, non-breast malignancies in ≤ 5 years prior to registration No history of allergy or hypersensitivity to capecitabine, paclitaxel, or fluorouracil No prior unanticipated severe reaction to fluoropyrimidine therapy No known DPD deficiency No known, existing uncontrolled coagulopathy No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements No lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medication No significant medical condition that would make treatment or follow-up on this protocol difficult or problematic, in the opinion of the treating oncologist No preexisting neuropathy > grade 0 PRIOR CONCURRENT THERAPY: No other concurrent cytotoxic agents, investigational drugs, immunotherapy, radiation therapy or hormonal therapy Capecitabine must not be administered together with antiviral drugs No concurrent allopurinol, metronidazole, or sorivudine (or its chemically-related analogues, such as brivudine) Cimetidine must be discontinued at least 2 weeks prior to start of study treatment and must be avoided while taking capecitabine Patients receiving bisphosphonates are eligible for this study No prior chemotherapy for metastatic disease Prior anthracycline and/or taxane in the neoadjuvant or adjuvant setting allowed if completed ≥ 6 months prior to registration Unlimited prior hormonal therapy allowed in the neoadjuvant, adjuvant, or metastatic setting No HIV-positive individuals receiving combination anti-retroviral therapy No major surgery, chemotherapy, or immunologic therapy ≤ 4 weeks prior to registration No radiotherapy ≤ 4 weeks prior to registration, except to a non-target lesion only Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed If patient receives single dose radiation for palliation, they may immediately proceed to registration without waiting 4 weeks Neoadjuvant and/or adjuvant therapy must be completed > 6 months prior to registration No current or recent use (≤ 2 weeks prior to registration) of aspirin, anticoagulants or thrombolytic agents Agents to maintain patency of a vascular access device is permitted

Ages Eligible for Study
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Minimum Age: 18 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: paclitaxel + capecitabine<br>Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for up to 5 years. | Drug: capecitabine<br> <br> Drug: paclitaxel poliglumex<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of confirmed tumor response (complete and partial response) as assessed by RECIST criteria |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time |  | Up to 5 years | 
| Time to disease progression |  | Up to 5 years | 

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