Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003369
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
1999-11-01
Brief Title:
S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic Recurrent or Refractory Cervical Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of tirapazamine plus cisplatin in treating patients who have metastatic recurrent or refractory cervical cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of tirapazamine plus cisplatin in treating patients who have metastatic recurrent or refractory cervical cancer
Detailed Description:
OBJECTIVES I Evaluate the survival of patients with metastatic or recurrent epithelial squamous or adenosquamous carcinoma of the cervix when treated with intravenous tirapazamine plus intravenous cisplatin II Evaluate the unconfirmed complete and partial response rates of these patients as well as the nature and degree of toxicity associated with this regimen in this patient population
OUTLINE Patients receive tirapazamine intravenously over 2 hours and then following a 1 hour rest receive cisplatin intravenously over 1 hour Courses are repeated every 21 days Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease progression All patients are followed every 6 months for 2 years then annually thereafter until death
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
OUTLINE Patients receive tirapazamine intravenously over 2 hours and then following a 1 hour rest receive cisplatin intravenously over 1 hour Courses are repeated every 21 days Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease progression All patients are followed every 6 months for 2 years then annually thereafter until death
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-S9717 | OTHER | None | None |