Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006012
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase I-II Study of Topotecan and Paclitaxel Followed by High-Dose Thoracic Radiation Therapy With Concomitant CisplatinEtoposide and Amifostine in Limited-Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 work in 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 cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy before during and after radiation therapy in treating patients who have limited-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy before during and after radiation therapy in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of thoracic radiotherapy administered with cisplatin etoposide and amifostine preceded and followed by topotecan and paclitaxel in patients with limited stage small cell lung cancer phase I closed to accrual as of 5272004
Determine the two-year survival of this patient population treated with this regimen
Determine the two-year progression-free local control rate in this patient population treated with this regimen
Assess the tolerability of this treatment regimen in these patients
Determine the antitumor activity of this regimen in these patients
Determine the overall survival and overall time to progression in this patient population treated with this regimen
OUTLINE This is a multicenter dose-escalation study of thoracic radiotherapy TRT
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5 Patients receive filgrastim G-CSF subcutaneously SC daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover Treatment repeats every 3 weeks for 2 courses
After 2 courses of topotecan and paclitaxel patients undergo TRT twice daily for 5 consecutive days for 5 weeks During TRT patients receive cisplatin IV oral etoposide and amifostine SC daily prior to TRT
At 4 weeks after completion of TRT patients receive 2 additional courses of topotecan paclitaxel and G-CSF every 3 weeks followed by prophylactic cranial irradiation
Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity phase I closed to accrual as of 5272004
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 3-73 patients will be accrued for this study phase I closed to accrual as of 5272004
Determine the maximum tolerated dose of thoracic radiotherapy administered with cisplatin etoposide and amifostine preceded and followed by topotecan and paclitaxel in patients with limited stage small cell lung cancer phase I closed to accrual as of 5272004
Determine the two-year survival of this patient population treated with this regimen
Determine the two-year progression-free local control rate in this patient population treated with this regimen
Assess the tolerability of this treatment regimen in these patients
Determine the antitumor activity of this regimen in these patients
Determine the overall survival and overall time to progression in this patient population treated with this regimen
OUTLINE This is a multicenter dose-escalation study of thoracic radiotherapy TRT
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5 Patients receive filgrastim G-CSF subcutaneously SC daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover Treatment repeats every 3 weeks for 2 courses
After 2 courses of topotecan and paclitaxel patients undergo TRT twice daily for 5 consecutive days for 5 weeks During TRT patients receive cisplatin IV oral etoposide and amifostine SC daily prior to TRT
At 4 weeks after completion of TRT patients receive 2 additional courses of topotecan paclitaxel and G-CSF every 3 weeks followed by prophylactic cranial irradiation
Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity phase I closed to accrual as of 5272004
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 3-73 patients will be accrued for this study phase I closed to accrual as of 5272004
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 |
|---|---|---|---|
| CDR0000068021 | REGISTRY | PDQ Physician Data Query | None |