Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003548
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2000-05-02
Brief Title:
Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase I Study of Intraperitoneal Administration of 9-Amino-20S-Camptothecin to Patients With Cancer Predominantly Confined to the Peritoneal Cavity
Status:
COMPLETED
Status Verified Date:
2011-03
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
PURPOSE Phase I trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity
PURPOSE Phase I trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity
Detailed Description:
OBJECTIVES I Determine the qualitative and quantitative toxicities of intraperitoneal aminocamptothecin colloidal dispersion administered every 28 days in 6 applications over a 12 day period in patients with advanced cancer confined to the peritoneal cavity II Determine the maximum tolerated dose of aminocamptothecin colloidal dispersion on this novel schedule in this patient population III Obtain pharmacological and biochemical data as potential predictors of responses andor drug toxicities in these patients IV Document the presence and degree of antitumor activity of this regimen in this patient population
OUTLINE This is a dose escalation study Patients receive intraperitoneal aminocamptothecin colloidal dispersion 9-AC over 30-60 minutes in 6 applications over a 12 day period days 1 3 5 8 10 and 12 Courses are repeated every 28 days Treatment continues for 4-6 courses in the absence of unacceptable toxic effects or disease progression The dose of 9-AC is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed until death
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for this study within 18 months
OUTLINE This is a dose escalation study Patients receive intraperitoneal aminocamptothecin colloidal dispersion 9-AC over 30-60 minutes in 6 applications over a 12 day period days 1 3 5 8 10 and 12 Courses are repeated every 28 days Treatment continues for 4-6 courses in the absence of unacceptable toxic effects or disease progression The dose of 9-AC is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed until death
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| NCI-T97-0123 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| U01CA076642 | NIH | None | None |
| P30CA016087 | NIH | None | None |
| NYU-9753 | None | None | None |