Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006391
Status:
COMPLETED
Last Update Posted:
2011-04-05
First Post:
2000-10-04
Brief Title:
Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase I Dose-Finding Study of Oxaliplatin NSC 266046 Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2011-04
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 combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial primary peritoneal or fallopian tube cancer
PURPOSE Phase I trial to study the effectiveness of combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial primary peritoneal or fallopian tube cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the antitumor activity of this treatment regimen in these patients
Determine the correlation between the pharmacokinetic and safety data of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed through day 30
PROJECTED ACCRUAL A minimum of 15 patients will be accrued for this study
Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the antitumor activity of this treatment regimen in these patients
Determine the correlation between the pharmacokinetic and safety data of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed through day 30
PROJECTED ACCRUAL A minimum of 15 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-690 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| U01CA070075 | NIH | None | None |
| P30CA016087 | NIH | None | None |
| NYU-0016 | None | None | None |