Metastatic Breast Cancer Clinical Trial
Official title:
A Phase II Trial of Capecitabine and Oxaliplatin (CAPOX) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE03-60
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 prior chemotherapy. Capecitabine was designed as an orally administered, tumor selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue. This trial will investigate the activity of this novel capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition, an exploratory analysis will correlate response with thymidine synthase and thymidine phosphorylase expression in primary tumor samples.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologic or cytologic diagnosis of breast cancer with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease.· - Patients with HER2 positive (3+ overexpression by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.· - At least one measurable lesion as defined by the RECIST. - Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. Exclusion Criteria: - 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.· - Maximum of one prior chemotherapy regimen for unresectable, locally recurrent or metastatic disease· - 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 female patients currently 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Elkhart Clinic | Elkhart | Indiana |
United States | Oncology Hematology Associates of SW Indiana | Evansville | Indiana |
United States | Medical & Surgical Specialists, LLC | Galesburg | Illinois |
United States | Community Regional Cancer Center | Indianapolis | Indiana |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | Quality Cancer Center (MCGOP) | Indianapolis | Indiana |
United States | Medical Consultants, P.C. | Muncie | Indiana |
United States | Center for Cancer Care, Inc., P.C. | New Albany | Indiana |
United States | Helen F. Graham Cancer Center | Newark | Delaware |
United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
United States | AP&S Clinic | Terre Haute | Indiana |
Lead Sponsor | Collaborator |
---|---|
Hoosier Cancer Research Network | Hoffmann-La Roche, Sanofi, Walther Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - To determine the objective response rate (CR+PR) of capecitabine and oxaliplatin (CAPOX) in patients with metastatic breast cancer. | 36 months | No | |
Secondary | To measure time to progression · | 36 months | No | |
Secondary | To determine rate of clinical benefit response (CR + PR + SD > 6 months). · | 36 months | No | |
Secondary | To determine toxicity rate of CAPOX in this patient population.· | 36 months | Yes | |
Secondary | To explore potential correlations between thymidine synthase (TS), thymidine phosphorylase (TP) and dihydropyrimidine dehydrogenase (DPD) expression in the primary tumor with response. | 36 months | No |
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