Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Breast Cancer, Non Small Cell Lung Cancer, Prostate Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Metronomic-therapy, vinorelbine, Recurrent Breast Cancer, Recurrent Non Small Cell Lung Cancer, Metastatic prostate cancer
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Henry Dunant Hospital
- Sotiria Hospital
- University Hospital "Attikon"
- Agii Anargiri Cancer Hospital
- Hygeia Hospital
- Metropolitan Hospital
- General Hospital of Chania
- University General Hospital of Ioannina, Medical Oncology Dept
- University Hospital of Patras
- "Theagenio" Hospital
- "Papageorgiou" Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
1
2
3