Status:
TERMINATED
Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Sanofi
Hoffmann-La Roche
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of patients with pri...
Detailed Description
OUTLINE: This is a multi-center study. * CAPOX-T (21 day cycle):Capecitabine 825 mg/m2 orally twice daily Days 1-14Oxaliplatin 100 mg/m2 intravenously Day 1 * Trastuzumab : 6 mg/kg intravenously Day ...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of breast cancer with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease.·
- HER2 gene amplification by FISH. HER protein overexpression by immunohistochemistry will not be sufficient for entry.·
- At least one measurable lesion as defined by the RECIST.
- Prior hormonal therapy for metastatic disease is allowed.
- Maximum of one prior chemotherapy regimen or trastuzumab-containing regimen for unresectable, locally recurrent or metastatic disease
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
Exclusion
- No prior therapy with capecitabine or oxaliplatin in any setting
- No prior therapy with other platinum compounds·
- No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to beginning protocol therapy.·
- No prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.·
- No prior fluoropyrimidine therapy for metastatic disease is allowed.
- Prior adjuvant fluoropyrimidine therapy is allowed if completed \> 12 months from study entry.·
- No symptomatic brain metastasis. ·
- No evidence of serious concomitant systemic disorders incompatible with the study ·
- No peripheral neuropathy ·
- No major surgery within 28 days prior to beginning protocol therapy.·
- Negative pregnancy test·
- No current breastfeeding·
- No malabsorption syndrome·
- No evidence of serious concomitant systemic disorders incompatible with the study·
- Patients must not be treated with any of the following while on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00216073
Start Date
March 1 2004
End Date
October 1 2006
Last Update
May 2 2011
Active Locations (11)
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1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
3
Elkhart Clinic
Elkhart, Indiana, United States, 46515
4
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815