Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003358
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
1999-11-01
Brief Title:
Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian Carcinoma
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 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 I trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with refractory or recurrent ovarian epithelial fallopian tube or primary peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with refractory or recurrent ovarian epithelial fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of intraperitoneal IP gemcitabine given in combination with IP cisplatin in patients with refractory or recurrent ovarian epithelial fallopian tube or primary peritoneal cancer II Determine the safety of this regimen in this patient population III Determine the pharmacokinetics of IP gemcitabine administered with IP cisplatin
OUTLINE This is a dose escalation study of gemcitabine Patients receive intraperitoneal cisplatin on day 1 plus intraperitoneal gemcitabine on days 1 8 and 15 No treatment will be given on day 22 Courses are repeated every 4 weeks Patients receive up to 4 courses of therapy Dose escalation of gemcitabine continues in cohorts of 3 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity DLT Patients are followed every 3 months for 2 years then every 6 months thereafter
PROJECTED ACCRUAL Approximately 3-24 patients will be accrued for this study
OUTLINE This is a dose escalation study of gemcitabine Patients receive intraperitoneal cisplatin on day 1 plus intraperitoneal gemcitabine on days 1 8 and 15 No treatment will be given on day 22 Courses are repeated every 4 weeks Patients receive up to 4 courses of therapy Dose escalation of gemcitabine continues in cohorts of 3 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity DLT Patients are followed every 3 months for 2 years then every 6 months thereafter
PROJECTED ACCRUAL Approximately 3-24 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 |
|---|---|---|---|
| NCI-H98-0016 | None | None | None |
| MSKCC-97129 | None | None | None |