Ovarian Cancer Clinical Trial
Official title:
INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and
kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining methotrexate and
dipyridamole in treating patients with advanced ovarian cancer that is recurrent after or
refractory to cisplatin-based chemotherapy.
OBJECTIVES: I. Determine the clinical complete and partial response rate, pathological
complete response rate, disease-free survival, and duration of response produced by
intraperitoneal dipyridamole/methotrexate (DP/MTX) administered as a 7-day continuous
infusion in patients with advanced ovarian carcinoma that is recurrent following or
refractory to cisplatin-based chemotherapy. II. Determine the peritoneal and systemic
toxicity of DP/MTX.
OUTLINE: Nonrandomized study. Single-Agent Chemotherapy with Chemopotentiation.
Methotrexate, MTX, NSC-740; with Dipyridamole, DP, NSC-515776.
PROJECTED ACCRUAL: Up to 40 evaluable patients in each category (prior intraperitoneal vs.
prior intravenous platinum-based chemotherapy) will be studied. If no responses are seen in
the first 20 patients in either category, accrual to that category will cease. An accrual
rate of 15 patients/year is anticipated.
;
Primary Purpose: Treatment
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