Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer
Inclusion 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
