NCT00002487

Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Ottawa Regional Cancer Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	dipyridamole
DRUG	methotrexate

Timeline

• Start date: 1991-07-01
• First posted: 2004-08-30
• Last updated: 2013-09-17

Locations

2 sites across 1 country: Canada