Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003117
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
1999-11-01
Brief Title:
Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Single-Agent Versus Combination Chemotherapy in Advanced NSCLC A CALGB Randomized Trial of Efficacy Quality of Life and Cost-Effectiveness
Status:
COMPLETED
Status Verified Date:
2016-06
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 III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating patients who have recurrent stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating patients who have recurrent stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the overall survival of patients with non-small cell lung cancer treated with paclitaxel alone or in combination with carboplatin II Compare the quality of life of these patients treated with these chemotherapy regimens III Compare the response rates and the toxic effects of the two regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to stage of disease stage IIIB vs stage IV vs recurrent or progressive after surgery andor radiotherapy performance status 0-1 vs 2 and age under 70 vs 70 and over Patients are randomized to one of two treatment arms Arm I receives paclitaxel IV over 3 hours on day 1 of each course Arm II receives paclitaxel as in Arm I followed by carboplatin IV over 1 hour Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or unacceptable toxicity Quality of life assessments are conducted before treatment and at 2 6 9 and 12 months Patients are followed every 3 months for 2 years then every 6 months until disease progression or death
OUTLINE This is a randomized study Patients are stratified according to stage of disease stage IIIB vs stage IV vs recurrent or progressive after surgery andor radiotherapy performance status 0-1 vs 2 and age under 70 vs 70 and over Patients are randomized to one of two treatment arms Arm I receives paclitaxel IV over 3 hours on day 1 of each course Arm II receives paclitaxel as in Arm I followed by carboplatin IV over 1 hour Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or unacceptable toxicity Quality of life assessments are conducted before treatment and at 2 6 9 and 12 months Patients are followed every 3 months for 2 years then every 6 months until disease progression or death
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 |
|---|---|---|---|
| CDR0000065871 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9730 | None | None | None |