Trial Information

A Phase I Feasibility Trial of Carboplatin and Topotecan Followed by Carboplatin and Paclitaxel (Sequential Doublets) in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma

OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin
and topotecan without excessive dose modification or course delay in patients with
previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the
response rate and progression-free interval in these patients with this treatment regimen.
III. Determine pharmacokinetic and pharmacodynamic parameters related to the sequence of
carboplatin and topotecan administration in these patients.

OUTLINE: Patients are assigned to one of three treatment regimens. Regimen I: Patients
receive carboplatin IV over 30 minutes on day 1 followed by topotecan IV over 30 minutes on
days 1-3. Treatment continues every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Regimen II: Patients
receive topotecan IV over 30 minutes on days 1-3 followed by carboplatin IV over 30 minutes
on day 3. Treatment continues every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Regimen III:
Patients receive topotecan IV over 30 minutes on days 1-5 followed by carboplatin IV over 30
minutes on day 5. Treatment continues every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes on day 1. Treatment continues every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Patients are
followed at 1 month and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 15-80 patients will be accrued for this study within 2 years.