Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003587
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
1999-11-01
Brief Title:
S9806 Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Randomized Phase II Trial of CarboplatinGemcitabine Followed By Paclitaxel or CisplatinVinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
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
PURPOSE Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel II Evaluate the response confirmed plus unconfirmed and toxicities associated with these two regimens in these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms Arm I Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for 3 courses Following the 3 courses of carboplatin and gemcitabine patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses Arm II Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8 Treatment repeats every 21 days for 3 courses Following the 3 courses of cisplatin and vinorelbine patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses Patients receive no further treatment until evidence of disease progression Patients are followed every 2 months for the first year every 6 months for years 2 and 3 and annually thereafter
PROJECTED ACCRUAL A total of 160 patients will be accrued for this study
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms Arm I Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for 3 courses Following the 3 courses of carboplatin and gemcitabine patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses Arm II Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8 Treatment repeats every 21 days for 3 courses Following the 3 courses of cisplatin and vinorelbine patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses Patients receive no further treatment until evidence of disease progression Patients are followed every 2 months for the first year every 6 months for years 2 and 3 and annually thereafter
PROJECTED ACCRUAL A total of 160 patients will be accrued for this study
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 |
|---|---|---|---|
| S9806 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |