Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Vinorelbine oral; Drug: Capecitabine

• Registration Number: NCT00706069
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

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

Detailed Description

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-27
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-14
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Vinorelbine oral	Vinorelbine oral plus Capecitabine
1	Capecitabine	Vinorelbine oral plus Capecitabine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Response Rate	Response evaluation at 3rd and 6th cycle by CT's or MRI

Trial Locations

Locations (4)

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

University General Hospital of Alexandroupolis, Dept. of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology; 🇬🇷 Athens, Greece

University Hospital of Crete, Dep of Medical Oncology; 🇬🇷 Heraklion, Greece