Ovarian Cancer Clinical Trial
Official title:
Phase II Trial of Cisplatin and Irinotecan in Patients With Suboptimally Debulked, Incompletely Responding Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and irinotecan in
treating patients who have ovarian, fallopian tube, or peritoneal cancer.
OBJECTIVES: I. Evaluate the antitumor effect of weekly cisplatin and irinotecan in patients
with suboptimally debulked ovarian, fallopian tube, or peritoneal cancer and persistently
elevated serum values of CA125 after 3 courses of standard therapy with paclitaxel and
either carboplatin or cisplatin. II. Evaluate the toxicity, both qualitative and
quantitative, of this regimen in this patient population. III. Evaluate the quality of life
of these patients.
OUTLINE: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90
minutes. Treatment is administered weekly for 4 weeks (days 1, 8, 15, and 22) followed by 2
weeks of rest. Patients receive at least 3 courses (18 weeks) of therapy in the absence of
disease progression or unacceptable toxicity. If patients demonstrate complete response to
treatment, they are encouraged to undergo second-look laparoscopy or laparotomy. Quality of
life is assessed before treatment, after the first course, and then after every 2 courses of
therapy. Patients are followed 30 days after the last treatment and then for survival.
PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 18-24 months.
;
Primary Purpose: Treatment
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