Status:
COMPLETED
Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
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 anthracycline...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00706069
Start Date
June 1 2008
End Date
July 1 2009
Last Update
December 15 2009
Active Locations (4)
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1
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli, Greece
2
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
3
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
4
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Greece