A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer
The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been
studied in a phase [I]/[II], with favourable profile of toxicity in pretreated patients with
anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003).
In a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR)
in 21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe
leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin
Oncol 19: Abstract 420, 2000)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination
Toxicity assessment at 1st cycle
Yes
Nikos Malamos, MD
Principal Investigator
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Greece: National Organization of Medicines
CT/07.06
NCT00706069
June 2008
July 2009
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