NCT00278070

Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Hellenic Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Non Small Cell Lung Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	vinorelbine oral formulation	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

Timeline

• Start date: 2006-01-01
• Completion: 2008-02-01
• First posted: 2006-01-18
• Last updated: 2008-02-29

Locations

11 sites across 1 country: Greece