Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022308
Status:
COMPLETED
Last Update Posted:
2013-09-02
First Post:
2001-08-10
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase I Trial of Radical Thoracic Radiation Weekly CPT-11 Irinotecan and Cisplatin in Locally Advanced Non-Small Cell Lung Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-08
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of irinotecan when administered with cisplatin and radiotherapy in patients with locally advanced non-small cell lung carcinoma II Determine the toxic effects especially acute and long-term esophagitis and pneumonitis of this regimen in these patients III Determine the response rate duration to progression and sites of relapse in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of irinotecan Patients receive irinotecan IV over 90 minutes and cisplatin over 1 hour on day 1 Patients also undergo radiotherapy once daily on days 1-5 Treatment repeats every 7 days for 7 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan 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 every 2 months for 1 year every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 3-27 patients will be accrued for this study within 3 years
OUTLINE This is a multicenter dose-escalation study of irinotecan Patients receive irinotecan IV over 90 minutes and cisplatin over 1 hour on day 1 Patients also undergo radiotherapy once daily on days 1-5 Treatment repeats every 7 days for 7 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of irinotecan 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 every 2 months for 1 year every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 3-27 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| P30CA006927 | NIH | None | None |
| FCCC-98020 | None | None | None |
| NCI-G01-1995 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |