A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma
- Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with
paclitaxel and carboplatin in patients with previously untreated ovarian epithelial,
peritoneal, or fallopian tube cancer.
- Determine the toxicity of this treatment regimen in these patients.
- Evaluate measurable disease in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox).
Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and
paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days
for 4 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of LipoDox 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 toxicity. An additional cohort of 12 patients receives
LipoDox at the MTD with carboplatin and paclitaxel as above.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Peter G. Rose, MD
MetroHealth Cancer Care Center at MetroHealth Medical Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|University of Texas Medical Branch||Galveston, Texas 77555-1329|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Holden Comprehensive Cancer Center||Iowa City, Iowa 52242-1009|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|