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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients will take three times a week \[Monday, Wednesday and Friday\] by mouth, a standard dose of soft capsules of vinorelbine given at dose ascribed by randomization procedure
Henry Dunant Hospital
Athens, Greece
Sotiria Hospital
Athens, Greece
University Hospital "Attikon"
Athens, Greece
Agii Anargiri Cancer Hospital
time to treatment failure
Time frame: TTF rates per arm will be compared at 4 and 6 months
progression free survival
Time frame: Patients will be assessed every 2 months during the first 6 months on treatment and every 4 months thereafter until documentation of objective tumor progression or death.
time to progression
Time frame: Patients will be assessed every 2 months during the first 6 months on treatment and every 4 months thereafter until documentation of objective tumor progression.
toxicity
Time frame: Acute toxicity will be assessed during the first 8 weeks, sub-acute 8 weeks to 4 months, chronic post 4 months
changes in blood concentrations of angiogenesis-associated surrogate markers and pharmacokinetics
Time frame: Baseline values will be assessed for predictive potential and assessment on weeks 2,4,8, 12 and thereafter every 2 months they will be analyzed for their capacity to act as surrogate markers of treatment activity
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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
Pátrai, Greece
"Theagenio" Hospital
Thessaloniki, Greece
...and 1 more locations