Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004209
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2000-01-21
Brief Title:
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Study of MVP 3 Versus 6 Cycles in Advanced Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2007-06
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 Combining more than one drug may kill more tumor cells It is not yet known whether three courses of combination chemotherapy are more effective than six courses of combination chemotherapy for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the duration of symptom control time to disease progression survival and quality of life in patients with stage IIIB or IV non-small cell lung cancer treated with 3 versus 6 courses of mitomycin vinblastine and cisplatin
OUTLINE This is a randomized multicenter study Patients are stratified by stage of disease stage IIIB vs IV Patients are randomized to 1 of 2 treatment arms Arm I Patients receive cisplatin IV over 4 hours mitomycin IV and vinblastine IV on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Mitomycin is not administered during course 3 Arm II Patients receive chemotherapy as in arm I Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Mitomycin is not administered during courses 3 and 5 Quality of life is assessed after completion of 3 courses of chemotherapy for patients in arm I and after completion of 4 5 and 6 courses for those in arm II Patients may receive radiotherapy beginning after completion of chemotherapy
PROJECTED ACCRUAL A total of 310 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified by stage of disease stage IIIB vs IV Patients are randomized to 1 of 2 treatment arms Arm I Patients receive cisplatin IV over 4 hours mitomycin IV and vinblastine IV on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Mitomycin is not administered during course 3 Arm II Patients receive chemotherapy as in arm I Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Mitomycin is not administered during courses 3 and 5 Quality of life is assessed after completion of 3 courses of chemotherapy for patients in arm I and after completion of 4 5 and 6 courses for those in arm II Patients may receive radiotherapy beginning after completion of chemotherapy
PROJECTED ACCRUAL A total of 310 patients 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-99017 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067457 | REGISTRY | None | None |