Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033696
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2002-04-09
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:
PaclitaxelTopotecanEtoposide EtopoTax Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer A Phase II Study
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 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 and radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel topotecan and etoposide followed by consolidation chemoradiotherapy
Determine the toxicity of this regimen in these patients
Determine the overall and failure-free survival of patients treated with this regimen
Determine the overall partial and complete response rate in patients treated with this induction chemotherapy regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive paclitaxel IV over 3 hours on days 1 and 22 oral topotecan on days 2-4 and 23-25 and oral etoposide on days 5-7 and 26-28 Patients also receive filgrastim G-CSF subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover
Consolidation therapy Patients receive carboplatin IV over 1 hour on days 43 64 and 85 and etoposide IV over 1 hour on days 43-45 64-66 and 85-87 Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks
Patients with rapid disease progression discontinue study therapy
Patients are followed at least every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 25-60 patients will be accrued for this study within 10 months
Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel topotecan and etoposide followed by consolidation chemoradiotherapy
Determine the toxicity of this regimen in these patients
Determine the overall and failure-free survival of patients treated with this regimen
Determine the overall partial and complete response rate in patients treated with this induction chemotherapy regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive paclitaxel IV over 3 hours on days 1 and 22 oral topotecan on days 2-4 and 23-25 and oral etoposide on days 5-7 and 26-28 Patients also receive filgrastim G-CSF subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover
Consolidation therapy Patients receive carboplatin IV over 1 hour on days 43 64 and 85 and etoposide IV over 1 hour on days 43-45 64-66 and 85-87 Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks
Patients with rapid disease progression discontinue study therapy
Patients are followed at least every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 25-60 patients will be accrued for this study within 10 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-30002 | None | None | None |
| CDR0000069313 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |