Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00002487|
Recruitment Status : Unknown
Verified April 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 30, 2004
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: dipyridamole Drug: methotrexate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA|
|Study Start Date :||July 1991|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002487
|Ottawa Regional Cancer Center - General Division|
|Ottawa, Ontario, Canada, K1H 8L6|
|Ottawa Regional Cancer Centre - Civic Campus|
|Ottawa, Ontario, Canada, K1Y 4K7|
|Study Chair:||Rakesh Goel, MD, FRCPC||Ottawa Regional Cancer Centre|