Status:
COMPLETED
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Lead Sponsor:
Hellenic Cooperative Oncology Group
Collaborating Sponsors:
University of Ioannina
Conditions:
Breast Cancer
Non Small Cell Lung Cancer
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic schedule three ...
Detailed Description
The purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema. \[Metronomic chemotherapy refers to the close, regular administrati...
Eligibility Criteria
Inclusion
- Signed informed consent
- Ages 16 - 75 years
- Genders: both
- Performance status 0-2 according to the World Health Organization (WHO) scale
- Life expectancy of at least 16 weeks
- Adequate bone marrow, hepatic and renal functions
- Absence of brain metastasis
- Metastatic/locally advanced refractory prostate, breast or non-small cell lung cancer previously treated with no more than two chemotherapeutic regimens
- White blood cells \>= 3500/mm\^3
- Absolute neutrophil count \>= 1500/mm\^3
- Platelets \>= 100,000/mm\^3
- Total serum bilirubin less than 1.5 mg/dl
- Serum transaminases less than 2.0 x upper normal limit (UNL) unless attributed to liver metastases
- Serum creatinine within normal range
Exclusion
- Major active infection
- More than two prior chemotherapy regimens for metastatic disease
- Any of the following within the 12 months prior to starting the study treatment:
- myocardial infarction,
- severe/unstable angina,
- coronary/peripheral artery bypass graft,
- congestive heart failure,
- cerebrovascular accident or transient ischemic attack, or pulmonary embolism,
- cardiac dysrhythmias of grade \>/= 2,
- atrial fibrillation of any grade, or
- heart rate corrected interval (QTc) \> 450 msec for males or \> 470 msec for females.
- Hypertension that cannot be controlled with medications (\> 150/100 mmHg despite optimal medical therapy)
- Ongoing anti-coagulation therapy
- Pregnancy or breastfeeding
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration; or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00278070
Start Date
January 1 2006
End Date
February 1 2008
Last Update
February 29 2008
Active Locations (11)
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1
Henry Dunant Hospital
Athens, Greece, 11526
2
Sotiria Hospital
Athens, Greece, 11526
3
University Hospital "Attikon"
Athens, Greece, 124 62
4
Agii Anargiri Cancer Hospital
Athens, Greece, 13122