Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003111
Status:
COMPLETED
Last Update Posted:
2013-07-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Phase II Clinical and Laboratory Study of IrinotecanCisplatin Chemotherapy Followed by Surgery in Stage III NSCLC
Status:
COMPLETED
Status Verified Date:
2009-08
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 combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES
Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer
Investigate the phenotypic changes induced in the tumor by this treatment
OUTLINE Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1 8 15 and 22 Treatment repeats every 6 weeks for 3 courses until disease progression Once potential candidates for resectability are determined patients undergo thoracotomy or concurrent chemotherapyradiation therapy within 6 weeks of completing the last course of chemotherapy Following resection patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel Chemotherapy ceases if disease remains stable after 8 weeks
Patients are followed every 3 months for the first year after treatment then every 6 months thereafter for survival
PROJECTED ACCRUAL This study will accrue 20 patients over 18 months
Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer
Investigate the phenotypic changes induced in the tumor by this treatment
OUTLINE Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1 8 15 and 22 Treatment repeats every 6 weeks for 3 courses until disease progression Once potential candidates for resectability are determined patients undergo thoracotomy or concurrent chemotherapyradiation therapy within 6 weeks of completing the last course of chemotherapy Following resection patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel Chemotherapy ceases if disease remains stable after 8 weeks
Patients are followed every 3 months for the first year after treatment then every 6 months thereafter for survival
PROJECTED ACCRUAL This study will accrue 20 patients over 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 |
|---|---|---|---|
| YALE-HIC-9317 | None | None | None |
| NCI-G97-1345 | None | None | None |