Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors
Recruitment status was: Active, not recruiting
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase I trial to compare the effectiveness of two different regimens of vinorelbine in treating patients who have metastatic or advanced solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: vinorelbine tartrate||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Absolute Bioavailability Study of Oral NAVELBINE (Vinorelbine Tartrate) in Patients With Solid Tumors|
|Study Start Date:||June 2000|
OBJECTIVES: I. Compare the pharmacokinetic profiles of vinorelbine administered intravenously on day 1 and orally on day 8 vs the reverse order in patients with metastatic or advanced solid tumors. II. Determine the intersubject variability in the pharmacokinetics of oral vinorelbine. III. Compare the safety profiles of oral vs intravenous vinorelbine in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive vinorelbine IV over 20 minutes on day 1 and oral vinorelbine on day 8. Arm II: Patients receive oral vinorelbine on day 1 and vinorelbine IV over 20 minutes on day 8. Treatment continues in both arms in the absence of unacceptable toxicity or disease progression. Patients are followed for 28 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006088
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Study Chair:||Daniel M. Sullivan, MD||H. Lee Moffitt Cancer Center and Research Institute|