Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002969
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
1999-11-01
Brief Title:
S9714 Paclitaxel 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:
Phase II Trial of Paclitaxel by 96-Hour Infusion in Stage IIIB and IV Bronchioloalveolar Carcinoma BAC
Status:
COMPLETED
Status Verified Date:
2012-07
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
PURPOSE Phase II trial to study the effectiveness of chemotherapy with paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy with paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Assess survival progression-free survival and response rate of patients with bronchioloalveolar carcinoma receiving paclitaxel II Evaluate toxic effects of paclitaxel in 96 hour continuous infusion patients
OUTLINE Patients receive 6 cycles of paclitaxel by IV continuous infusion over 96 hours Before cycle 4 restaging is performed If disease progression is witnessed patients are removed from the study If a stable partial or complete response is observed patients receive the total of 6 cycles Three weeks after the last cycle final restaging is performed Patients are followed every 3 months while on treatment and every 6 months thereafter unless more frequent follow-up is clinically recommended
PROJECTED ACCRUAL 50 patients will be enrolled The accrual rate is estimated at 25 per year
OUTLINE Patients receive 6 cycles of paclitaxel by IV continuous infusion over 96 hours Before cycle 4 restaging is performed If disease progression is witnessed patients are removed from the study If a stable partial or complete response is observed patients receive the total of 6 cycles Three weeks after the last cycle final restaging is performed Patients are followed every 3 months while on treatment and every 6 months thereafter unless more frequent follow-up is clinically recommended
PROJECTED ACCRUAL 50 patients will be enrolled The accrual rate is estimated at 25 per year
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 |
|---|---|---|---|
| S9714 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |