Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004887
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-03-07
Brief Title:
Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
Sponsor:
The Christie NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Comparative Study of Paclitaxel With Carboplatin Versus Mitomycin Ifosfamide Cisplatin MIC Chemotherapy in Inoperable Advanced Stage Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2000-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 It is not yet known whether paclitaxel and carboplatin is more effective than standard chemotherapy for advanced non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery
Detailed Description:
OBJECTIVES
Compare the one and two year survival of patients with inoperable advanced non-small cell lung cancer treated with paclitaxel and cisplatin versus standard platinum therapy
Compare the toxic effects of these two regimens in this patient population
Compare the performance status tumor response and quality of life in these patients after these treatment regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to center stage of disease IIIA vs IIIB vs IV or performance status ECOG O vs 1 vs 2 vs 3
Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1
Arm II Patients receive mitomycin IV ifosfamide IV over 3 hours and cisplatin IV over 1 hour on day 1 OR mitomycin IV vinblastine IV and cisplatin IV over 4 hours on day 1
Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before each treatment course
Patients are followed for survival
PROJECTED ACCRUAL Approximately 300 patients 150 per treatment arm will be accrued for this study
Compare the one and two year survival of patients with inoperable advanced non-small cell lung cancer treated with paclitaxel and cisplatin versus standard platinum therapy
Compare the toxic effects of these two regimens in this patient population
Compare the performance status tumor response and quality of life in these patients after these treatment regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to center stage of disease IIIA vs IIIB vs IV or performance status ECOG O vs 1 vs 2 vs 3
Patients are randomized to one of two treatment arms
Arm I Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1
Arm II Patients receive mitomycin IV ifosfamide IV over 3 hours and cisplatin IV over 1 hour on day 1 OR mitomycin IV vinblastine IV and cisplatin IV over 4 hours on day 1
Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before each treatment course
Patients are followed for survival
PROJECTED ACCRUAL Approximately 300 patients 150 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| EU-99046 | None | None | None |
| CHNT-PCMIC | None | None | None |