Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006004
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2000-07-05
Brief Title:
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-06
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 It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare overall survival response rate and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin
Compare the toxicities of each of these 2 regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to weight loss in the past 6 months less than 5 vs at least 5 and disease stage stage IIIB with pleural or pericardial effusion or pleural implants vs stage IVrecurrent Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only
Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 40-90 patients 20-45 per arm will be accrued for this study within 12 months
Compare overall survival response rate and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin
Compare the toxicities of each of these 2 regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to weight loss in the past 6 months less than 5 vs at least 5 and disease stage stage IIIB with pleural or pericardial effusion or pleural implants vs stage IVrecurrent Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only
Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 40-90 patients 20-45 per arm will be accrued for this study within 12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-1599 | None | None | None |