Status:
COMPLETED
Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizum...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with metastatic breast cancer treated with docetaxel, capecitabine, and bevacizumab as first-line chemotherapy. Secondary * Determine ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00088998
Start Date
December 1 2004
End Date
December 1 2010
Last Update
December 7 2016
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