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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00706069 |
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Date of registration:
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25/06/2008 |
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Primary sponsor: |
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Public title:
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Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer
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Scientific title:
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A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00706069 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Greece
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Contacts
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Name:
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Nikos Malamos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Intervention(s)
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Drug: Capecitabine
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Drug: Vinorelbine oral
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Primary Outcome(s)
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Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination.
[Time Frame: Toxicity assessment at 1st cycle]
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Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination
[Time Frame: Toxicity assessment at 1st cycle]
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Secondary Outcome(s)
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Response Rate
[Time Frame: Response evaluation at 3rd and 6th cycle by CT's or MRI]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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