Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004201
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2000-01-21
Brief Title:
Gemcitabine Plus Carboplatin or Cisplatin in Treating Patients With Stage IIIB Stage IV or Recurrent Non-small Cell Lung Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of Cisplatin or Carboplatin With Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2007-06
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 II trial to compare the effectiveness of gemcitabine plus carboplatin with that of gemcitabine plus cisplatin in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of gemcitabine plus carboplatin with that of gemcitabine plus cisplatin in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the response rates of gemcitabine and carboplatin vs gemcitabine and cisplatin in patients with stage IIIB IV or recurrent non-small cell lung cancer II Determine the toxicity of these two regimens in this patient population III Determine the time to progression and one year survival of these patients on these regimens
OUTLINE This is a randomized study Patients are stratified by stage of disease and gender Patients are randomized to one of two treatment arms Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin over 60 minutes on day 1 Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 60 minutes on day 1 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients are followed monthly for 3 months every two months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 1 year
OUTLINE This is a randomized study Patients are stratified by stage of disease and gender Patients are randomized to one of two treatment arms Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin over 60 minutes on day 1 Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 60 minutes on day 1 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients are followed monthly for 3 months every two months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study within 1 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 |
|---|---|---|---|
| CPMC-IRB-9027 | None | None | None |