Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054392
Status:
WITHDRAWN
Last Update Posted:
2013-07-11
First Post:
2003-02-05
Brief Title:
Combination Chemotherapy in Treating Patients With Stage IIIB Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Randomized Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic Stage IIIB IV Non-Small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not opened at Fox Chase Cancer Center
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 such as gemcitabine carboplatin and paclitaxel 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 which chemotherapy regimen is more effective in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin
Compare the overall response rate and time to progression in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to weight loss within the past 6 months less than 5 vs at least 5 disease stage IIIB vs IV and brain metastases present vs absent Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1
Arm III Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1
In all arms treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 6 weeks during study treatment and then every 3 months until progressive disease is documented
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 1134 patients 378 per treatment arm will be accrued for this study within 2 years
Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin
Compare the overall response rate and time to progression in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to weight loss within the past 6 months less than 5 vs at least 5 disease stage IIIB vs IV and brain metastases present vs absent Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1
Arm III Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1
In all arms treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 6 weeks during study treatment and then every 3 months until progressive disease is documented
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 1134 patients 378 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000270434 | REGISTRY | PDQ Physician Data Query | None |