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Brief Title: Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Official Title: Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study
Study ID: NCT00278070
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 times a week: on Monday, Wednesday and Friday.
Detailed Description: The purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema. \[Metronomic chemotherapy refers to the close, regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no drug-free breaks, over prolonged periods\]. Patients with recurrent or metastatic solid tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or 50 mg). Treatment is administered three times a week (Monday, Wednesday and Friday) continuously until disease progression or unacceptable toxicity or to a maximum of 24 months.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Henry Dunant Hospital, Athens, , Greece
Sotiria Hospital, Athens, , Greece
University Hospital "Attikon", Athens, , Greece
Agii Anargiri Cancer Hospital, Athens, , Greece
Hygeia Hospital, Athens, , Greece
Metropolitan Hospital, Athens, , Greece
General Hospital of Chania, Chania, , Greece
University General Hospital of Ioannina, Medical Oncology Dept, Ioannina, , Greece
University Hospital of Patras, Patras, , Greece
"Theagenio" Hospital, Thessaloniki, , Greece
"Papageorgiou" Cancer Hospital, Thessaloniki, , Greece
Name: Evangelos Briasoulis, MD
Affiliation: Assistant Professor of Oncology, Medical School, University of Ioannina
Role: PRINCIPAL_INVESTIGATOR