Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
- Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with
carboplatin in patients with gynecological tumors.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the kind, frequency, severity, and duration of adverse events in patients
treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome.
Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over
30 minutes on day 1. Treatment repeats every 28 days for 6 courses.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, additional patients are accrued and treated at the MTD as above.
Patients are followed at 4-6 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
DLT during first 3 cycles
Andreas du Bois, MD, PhD
Germany: Federal Institute for Drugs and Medical Devices