Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer
NCT ID: NCT00706069
Last Updated: 2009-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2008-06-30
2009-07-31
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Vinorelbine oral plus Capecitabine
Vinorelbine oral
Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday
Capecitabine
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
Interventions
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Vinorelbine oral
Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday
Capecitabine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
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Hellenic Oncology Research Group
Principal Investigators
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Nikos Malamos, MD
Role: PRINCIPAL_INVESTIGATOR
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Locations
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University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli, , Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, , Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, , Greece
University Hospital of Crete, Dep of Medical Oncology
Heraklion, , Greece
Countries
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Other Identifiers
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CT/07.06
Identifier Type: -
Identifier Source: org_study_id