Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003345
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Cisplatin Plus Irinotecan in Treating Patients With Ovarian Fallopian Tube or Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Cisplatin and Irinotecan in Patients With Suboptimally Debulked Incompletely Responding Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 combining cisplatin and irinotecan in treating patients who have ovarian fallopian tube or peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of combining cisplatin and irinotecan in treating patients who have ovarian fallopian tube or peritoneal cancer
Detailed Description:
OBJECTIVES I Evaluate the antitumor effect of weekly cisplatin and irinotecan in patients with suboptimally debulked ovarian fallopian tube or peritoneal cancer and persistently elevated serum values of CA125 after 3 courses of standard therapy with paclitaxel and either carboplatin or cisplatin II Evaluate the toxicity both qualitative and quantitative of this regimen in this patient population III Evaluate the quality of life of these patients
OUTLINE Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90 minutes Treatment is administered weekly for 4 weeks days 1 8 15 and 22 followed by 2 weeks of rest Patients receive at least 3 courses 18 weeks of therapy in the absence of disease progression or unacceptable toxicity If patients demonstrate complete response to treatment they are encouraged to undergo second-look laparoscopy or laparotomy Quality of life is assessed before treatment after the first course and then after every 2 courses of therapy Patients are followed 30 days after the last treatment and then for survival
PROJECTED ACCRUAL There will be 12-35 patients accrued into this study over 18-24 months
OUTLINE Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90 minutes Treatment is administered weekly for 4 weeks days 1 8 15 and 22 followed by 2 weeks of rest Patients receive at least 3 courses 18 weeks of therapy in the absence of disease progression or unacceptable toxicity If patients demonstrate complete response to treatment they are encouraged to undergo second-look laparoscopy or laparotomy Quality of life is assessed before treatment after the first course and then after every 2 courses of therapy Patients are followed 30 days after the last treatment and then for survival
PROJECTED ACCRUAL There will be 12-35 patients accrued into this study over 18-24 months
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 |
|---|---|---|---|
| CDR0000066322 | REGISTRY | None | None |
| NCI-H98-0013 | Registry Identifier | PDQ Physician Data Query | None |