Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoosier Cancer Research Network
• Collaborators: Hoffmann-La Roche; Sanofi; Walther Cancer Institute
• Treatments: Capecitabine; Oxaliplatin

Criteria

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.