Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003299
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-11-01
Brief Title:
Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide Cisplatin and Paclitaxel in Patients With Extensive 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 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 It is not yet known whether cisplatin etoposide and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Determine whether the addition of paclitaxel to standard chemotherapy treatment comprising etoposide and cisplatin improves the survival of patients with extensive stage small cell lung cancer II Compare the tumor response rate and failure-free survival of these patients treated with these regimens III Describe and compare the toxic effects associated with these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to performance status and gender Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV on day 1 and etoposide IV over 1 hour on days 1-3 Arm II Patients receive paclitaxel IV over 3 hours on day 1 and cisplatin and etoposide as in arm I Patients then receive filgrastim G-CSF subcutaneously on days 4-18 Treatment repeats in both arms every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at least every 2 months for 2 years every 4 months for 1 year and then at least every 6 months for 2 years
PROJECTED ACCRUAL Approximately 670 patients 335 per arm will be accrued for this study within 16 months
OUTLINE This is a randomized study Patients are stratified according to performance status and gender Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV on day 1 and etoposide IV over 1 hour on days 1-3 Arm II Patients receive paclitaxel IV over 3 hours on day 1 and cisplatin and etoposide as in arm I Patients then receive filgrastim G-CSF subcutaneously on days 4-18 Treatment repeats in both arms every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at least every 2 months for 2 years every 4 months for 1 year and then at least every 6 months for 2 years
PROJECTED ACCRUAL Approximately 670 patients 335 per arm will be accrued for this study within 16 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 |
|---|---|---|---|
| CDR0000066238 | REGISTRY | NCI Physician Desk Reference | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9732 | None | None | None |
| E-C9732 | None | None | None |
| NCCTG-C9732 | None | None | None |
| SWOG-C9732 | None | None | None |