Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.
PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.
Drug: doxorubicin hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer|
- Acute toxicity [ Designated as safety issue: Yes ]
- Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I) [ Designated as safety issue: Yes ]
- Primary efficacy and safety (phase II) [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
- To determine the maximum tolerated dose and safety of intravenous doxorubicin hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive recurrent ovarian cancer.
- To evaluate the feasibility of this regimen in these patients.
- To evaluate the response rate and progression-free survival of patients with recurrent ovarian cancer who have had no more than two prior salvage regimens.
OUTLINE: This is a phase I dose-escalation study of carboplatin followed by a phase II study.
- Phase I: Patients receive doxorubicin hydrochloride IV over 1 hour followed by carboplatin intraperitoneally on day 1 until the maximum tolerated dose is achieved. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive doxorubicin hydrochloride as in phase I and carboplatin at the maximum tolerated dose as in phase I.
After completion of study treatment, patients are followed every 4 weeks for 1 year.
PROJECTED ACCRUAL: A total of 61 patients (18 patients in phase I and 43 patients in phase II) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562185
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Study Chair:||Jayanthi S. Lea, MD||Simmons Cancer Center|