Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003154
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of 9-Aminocamptothecin 9-AC Colloidal Dispersion CD 120-Hour Continuous Intravenous Infusion in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-06
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
PURPOSE Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine whether aminocamptothecin colloidal dispersion ACCD administered as a 120 hour weekly infusion is an effective treatment for advanced non-small cell lung cancer II Observe any toxicities associated with this treatment in this patient population
OUTLINE Patients receive a 120 hour continuous infusion of aminocamptothecin colloidal dispersion ACCD once a week for 2 weeks followed by 1 week of rest Patients are assessed after every 2 courses of therapy Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced Patients are followed every 3 months
PROJECTED ACCRUAL A total of 19-36 patients will be accrued for this study
OUTLINE Patients receive a 120 hour continuous infusion of aminocamptothecin colloidal dispersion ACCD once a week for 2 weeks followed by 1 week of rest Patients are assessed after every 2 courses of therapy Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced Patients are followed every 3 months
PROJECTED ACCRUAL A total of 19-36 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-T97-0024 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-1597 | OTHER | None | None |
| U01CA063200 | NIH | None | None |