Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer
bevacizumab
+ capecitabine
+ docetaxel
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: December 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the response rate in patients with metastatic breast cancer treated with docetaxel, capecitabine, and bevacizumab as first-line chemotherapy. Secondary * Determine time to disease progression in patients treated with this regimen. * Determine survival of patients treated with this regimen. * Determine the toxicity profile of this regimen in these patients. * Determine the duration of response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.46 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive breast cancer * Clinical evidence of metastatic disease * No bone metastases as the only evidence of metastasis * Measurable disease * At least 1 lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan * Lesions on chest x-ray allowed provided they are clearly defined and surrounded by aerated lung * Clincal lesions only considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes) * Target lesion must not have been exposed to prior radiotherapy unless disease has progressed since completion of radiotherapy * The following are not considered measurable disease: * Bone lesions * Leptomeningeal disease * Ascites * Pleural or pericardial effusion * Inflammatory breast disease * Lymphangitis cutis or pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * No HER2/neu-positive tumors by immunohistochemistry or amplified fluorescence in situ hybridization unless disease has progressed after trastuzumab (Herceptin®)-containing therapy alone or with antiestrogen hormonal therapy for metastatic disease OR trastuzumab is contraindicated * Prior breast cancer allowed * No prior or active brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * No bleeding diathesis or uncontrolled coagulopathy Hepatic * Bilirubin normal * Meets 1 of the following criteria: * AST and ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN * AST and ALT ≤ 5 times ULN AND alkaline phosphatase normal Renal * Creatinine clearance ≥ 30 mL/min * No proteinuria OR * Protein \< 1 g by 24-hour urine collection * No nephrotic syndrome Cardiovascular * No uncontrolled hypertension (i.e., blood pressure \> 160/90 mm Hg on ≥ 2 different observations ≥ 5 minutes apart) * Blood pressure \< 140/90 mm Hg on ≥ 3 different observations over ≥ 14 days, for patients who recently began or adjusted anti-hypertensive medication * No atrial or venous thrombosis within the past month * No clinically significant heart disease, including any of the following: * Congestive heart failure * Symptomatic coronary artery disease * Uncontrolled cardiac arrhythmias * Unstable angina * No myocardial infarction within the past 12 months * No history of cerebrovascular accident Pulmonary * No hemoptysis within the past 6 months Gastrointestinal * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * Able to receive oral medication Other * No other stage III or IV invasive malignancy requiring treatment within the past 5 years * No pre-existing peripheral neuropathy \> grade 1 * No history of allergy or hypersensitivity to study drugs, agents that are chemically similar to study drugs, or drugs that contain polysorbate 80 * No prior severe reaction to fluoropyrimidines * No known hypersensitivity to fluorouracil * No known dihydropyrimidine dehydrogenase deficiency * No active infection * No significant medical condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No other concurrent biologic therapy Chemotherapy * Prior adjuvant or neoadjuvant chemotherapy allowed for primary disease * No prior chemotherapy for metastatic disease * More than 4 weeks since prior cytotoxic chemotherapy * More than 6 months since prior taxanes (e.g., docetaxel or paclitaxel) * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * Prior antiestrogen hormonal therapy allowed in the adjuvant or metastatic setting Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy to a target lesion * Prior single-dose palliative radiotherapy allowed within the past 4 weeks * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery Other * More than 2 weeks since prior aspirin, anticoagulants, or thrombolytic agents * Concurrent low-dose warfarin (1 mg/day) to maintain patency of vascular access device allowed * More than 4 weeks since prior investigational agents * No concurrent aspirin, anticoagulants, or thrombolytic agents * No concurrent participation in another clinical trial involving investigational agents or procedures
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives