Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.
PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: topotecan hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|
- Frequency and duration of objective response [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
- Duration of progression-free survival [ Designated as safety issue: No ]
- Duration of overall survival [ Designated as safety issue: No ]
- Prognostic variables including initial performance status, age, mucinous (or clear cell) histology, and platinum-free interval [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
- Determine the duration of progression-free survival and overall survival in patients treated with these regimens.
- Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.
Show 78 Study Locations
|Study Chair:||Thomas J. Herzog, MD||Herbert Irving Comprehensive Cancer Center|
|Investigator:||David E. Cohn, MD||Ohio State University Comprehensive Cancer Center|