Ovarian Cancer Clinical Trial
Official title:
A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who
have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.
OBJECTIVES:
- Determine the response rate and time to treatment failure in patients with recurrent
ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with
CT-2103.
- Determine the tolerability and safety of the previously established dose and schedule
of CT-2103 in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive CT-2103 IV over 10 minutes on day 1. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.
If no more than 1 of the first 6 patients experience dose-limiting toxicity, then the
remaining patients receive a higher dose of CT-2103.
Patients are followed between 1-3 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
;
Primary Purpose: Treatment
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