Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
This study is not yet open for patient recruitment.
Sponsored by: |
North Central Cancer Treatment Group
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in different ways to stop tumor cells from
dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them
or deliver tumor killing substances to them without harming normal cells. Combining capecitabine and vinorelbine with trastuzumab
may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and vinorelbine with trastuzumab in treating
patients who have metastatic breast cancer.
Condition
|
Treatment or Intervention |
Phase |
recurrent breast cancer stage IV breast cancer Male Breast Cancer
|
Drug: capecitabine Drug: trastuzumab Drug: vinorelbine Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: monoclonal antibody therapy
|
Phase II
|
MedlinePlus related topics: Breast Cancer; Male Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Capecitabine, Vinorelbine, and Trastuzumab (Herceptin®) as First-Line Treatment in Patients With HER2/neu-Overexpressing
Metastatic Breast Cancer
Further Study Details:
OBJECTIVES: Primary
- Determine the overall response rate in patients with HER2/neu-overexpressing metastatic breast cancer treated with first-line
therapy comprising capecitabine, vinorelbine, and trastuzumab (Herceptin^®).
Secondary
- Determine the time to disease progression, duration of response, and overall survival of patients treated with this regimen.
- Determine the safety profile of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10 minutes on days 1 and 8, and trastuzumab
(Herceptin^®) IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 5-47 patients will be accrued for this study within 23 months.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer
- Metastatic disease
- HER2/neu-positive by immunohistochemistry (3+ by HercepTest
- or equivalent) OR positive for amplification by fluorescent in situ hybridization
- Testing may be performed in the primary tumor or the metastatic site
- Disease progression after prior adjuvant or neoadjuvant taxane-based therapy
- Measurable disease
- At least one measurable lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan
- The following are considered non-measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No bone metastases as the only evidence of metastasis
- No known CNS metastases
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm^3
- No known uncontrolled coagulopathy
Hepatic
- Bilirubin ≤ 3.0 times the upper limit of normal (ULN)
- One of the following must be true:
- AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- INR ≤ 1.5 times ULN
- PT normal
Renal
- Calcium ≤ 11.5 mg/dL
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 30 mL/min
Cardiovascular
- LVEF ≥ 50% by MUGA or echocardiogram
- No clinically significant (i.e., active) cardiac disease
- No congestive heart failure
- No symptomatic coronary artery disease
- No myocardial infarction within the past 12 months
- No cardiac arrhythmia not controlled with medication
Gastrointestinal
- Able to take oral medication
- No lack of physical integrity of the upper gastrointestinal tract
- No clinically significant malabsorption syndrome
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after study participation
- No history of allergy or hypersensitivity to study drugs, drug product excipients, including polysorbate 80, or chemically
similar agents
- No prior unanticipated severe reaction to fluoropyrimidine therapy
- No know hypersensitivity to fluorouracil
- No known dihydropyrimidine dehydrogenase deficiency
- No history of uncontrolled seizures or CNS disorders
- No clinically significant psychiatric disability that would preclude giving informed consent or study compliance
- No other serious uncontrolled infection or disease
- No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix, or contralateral
breast cancer
PRIOR CONCURRENT THERAPY: Biologic therapy
- Prior adjuvant trastuzumab (Herceptin^®) allowed
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy in the metastatic (non-adjuvant) setting
- No prior continuous (≥ 24 hours) fluorouracil infusion
- No prior capecitabine
- No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and tegafur, S1, or emitefur)
Endocrine therapy
- At least 1 day since prior hormonal therapy
- No concurrent hormonal therapy
Radiotherapy
- More than 4 weeks since prior radiotherapy to the axial skeleton
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery
- No prior organ allografts requiring immunosuppressive therapy
Other
- More than 4 weeks since prior participation in an investigational drug study
- No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
- No other concurrent cytotoxic agents
- No other concurrent investigational drugs
- No other concurrent anticancer therapy
Location
Information
Study chairs or principal investigators
Winston Tan, MD, Study Chair, Mayo Clinic - Jacksonville
Muhammad Salim, MD, Allan Blair Cancer Centre at Pasqua Hospital
Edith A. Perez, MD, Mayo Clinic - Jacksonville
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000390344; NCCTG-N0337
Record last reviewed:
September 2004
Record first received:
October 6, 2004
ClinicalTrials.gov Identifier:
NCT00093808Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-09