Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Capecitabine; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic breast cancer

• Age 18-75 years

• Bidimensionally measurable or evaluable disease

• Performance status (PS) 0-2 (ECOG)

• Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment

• Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and adequate bone marrow function(neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)

• At least three weeks from completion of irradiation

• Life expectancy ≥ 12 weeks

• Patients able to take oral medication

• written informed consent

Exclusion Criteria:

• Active infection

• Brain metastases

• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

• Malnutrition (loss of ≥ 20% of the original body weight)

• Psychiatric illness or social situation that would preclude study compliance

• Pregnant or lactating women