Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003127
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
1999-11-01
Brief Title:
S9720 Combination Chemotherapy in Treating Patients With Metastatic Recurrent or Refractory Endometrial Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of Paclitaxel and Carboplatin With Amifostine in Advanced Recurrent or Refractory Endometrial Adenocarcinoma
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 in treating patients with metastatic recurrent or refractory endometrial cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic recurrent or refractory endometrial cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy of paclitaxel and carboplatin with amifostine on progression free survival and overall survival in patients with metastatic or recurrent epithelial endometrial carcinoma not amenable to surgery or radiotherapy II Evaluate response confirmed and unconfirmed partial response and complete response rate to this regimen in this patient population III Assess the nature and degree of toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours then amifostine IV over 10 minutes followed fifteen minutes later by carboplatin IV over 30-60 minutes on day 1 Courses repeat every 28 days Treatment continues for 6 courses in the absence of disease progression Patients are followed every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 35 to 50 patients will be accrued for this study
OUTLINE Patients receive paclitaxel IV over 3 hours then amifostine IV over 10 minutes followed fifteen minutes later by carboplatin IV over 30-60 minutes on day 1 Courses repeat every 28 days Treatment continues for 6 courses in the absence of disease progression Patients are followed every 6 months for 2 years then annually thereafter
PROJECTED ACCRUAL A total of 35 to 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-S9720 | OTHER | None | None |