Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine
- Determine the pharmacokinetic profile of gemcitabine, doxorubicin HCl liposome, and
vinorelbine in patients with advanced solid tumors.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is a dose escalation study.
Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1, gemcitabine IV over
30 minutes on days 1 and 8, and vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment
continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, gemcitabine,
and vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting
Patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: Approximately 9-24 patients will be accrued for this study within 12-18
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Beth A. Overmoyer, MD, FACP
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|