Viewing Study NCT00059761



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Study NCT ID: NCT00059761
Status: COMPLETED
Last Update Posted: 2015-11-17
First Post: 2003-05-06

Brief Title: Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor: Radiation Therapy Oncology Group
Organization: Radiation Therapy Oncology Group

Study Overview

Official Title: Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy 45 Gy or Once Daily Thoracic Radiotherapy 70 Gy for Patients With Limited Stage Small Cell Lung Cancer
Status: COMPLETED
Status Verified Date: 2015-11
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 effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery
Detailed Description: OBJECTIVES

Determine the maximum tolerated dose of irinotecan administered with cisplatin and thoracic radiotherapy given at two different schedules in patients with limited stage small cell lung cancer
Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of these regimens in these patients
Determine the reversibility of all toxic effects associated with these regimens in these patients

OUTLINE This is a non-randomized dose-escalation study of irinotecan Patients are assigned to 1 of 2 radiotherapy RT treatment groups

Radiotherapy

Group I Patients undergo thoracic RT twice daily 5 days a week for 3 weeks
Group II Patients undergo thoracic RT once daily 5 days a week for 7 weeks
Concurrent chemotherapy Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II
Post RT chemotherapy Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses beginning after RT is complete for group II

Sequential cohorts of 6 patients per group 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 6 patients experience dose-limiting toxicity

Patients are followed every 3 months for 1 year and then 6 months for 4 years

PROJECTED ACCRUAL A total of 12-36 patients 6-18 per group 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
CDR0000269348 None None None