Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

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

Detailed Description
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The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been studied in a phase [I]/[II], with favourable profile of toxicity in pretreated patients with anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003). In a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR) in 21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin Oncol 19: Abstract 420, 2000)

Official Title
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A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Vinorelbine oral
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Vinorelbine oral plus Capecitabine | Drug: Vinorelbine oral<br>* Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday<br>* Other names: Navelbine oral;Drug: Capecitabine<br>* Capecitabine at dose levels of 800 mg/m2, 950mg/m2, 1100mg/m2, 1250mg/m2 per os from day 1 to day 14 every 21 days<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination |  | Toxicity assessment at 1st cycle | 
| Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination. |  | Toxicity assessment at 1st cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | Response evaluation at 3rd and 6th cycle by CT's or MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Cancer, Vinorelbine oral, Capecitabine