Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003896
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
1999-11-01
Brief Title:
S9912 Combination Chemo in Stage III Ovarian Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Evaluation of Intravenous Paclitaxel Intraperitoneal Cisplatin Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 work in 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 combining paclitaxel cisplatin and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer fallopian tube cancer or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel cisplatin and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer fallopian tube cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of intraperitoneal IP cisplatin IP and IV paclitaxel and IV doxorubicin HCl liposome in terms of progression-free survival and overall survival in patients with optimally debulked stage III ovarian epithelial fallopian tube or primary peritoneal cancer
Determine the feasibility of and toxic effects associated with this regimen in these patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours on day 1 intraperitoneal IP cisplatin over 30-60 minutes on day 2 IP paclitaxel over 30-60 minutes on day 8 and doxorubicin HCl liposome IV over 1 hour on day 8 Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study within 4 years
Determine the efficacy of intraperitoneal IP cisplatin IP and IV paclitaxel and IV doxorubicin HCl liposome in terms of progression-free survival and overall survival in patients with optimally debulked stage III ovarian epithelial fallopian tube or primary peritoneal cancer
Determine the feasibility of and toxic effects associated with this regimen in these patients
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours on day 1 intraperitoneal IP cisplatin over 30-60 minutes on day 2 IP paclitaxel over 30-60 minutes on day 8 and doxorubicin HCl liposome IV over 1 hour on day 8 Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| S9912 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |