Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002487
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer
Sponsor:
Ottawa Regional Cancer Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA
Status:
UNKNOWN
Status Verified Date:
2000-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 dipyridamolemethotrexate DPMTX 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 DPMTX
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 patientsyear is anticipated
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 patientsyear is anticipated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-OTT-9017 | None | None | None |
| NCI-V92-0012 | None | None | None |