Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

Sponsor
Hellenic Cooperative Oncology Group
Study ID
NCT00278070
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • vinorelbine oral formulation — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 31, 2006
Status verified
Feb 2008
Completion
Feb 29, 2008

Study Design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
  • Active Comparator: 2
  • Active Comparator: 3

Primary Outcome Measure

time to treatment failure [ Time Frame: TTF rates per arm will be compared at 4 and 6 months ]

Related Studies