Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017459
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2001-06-06
Brief Title:
Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Sanofi
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The International Tirazone Triple Trial i3T A Phase III Randomized Efficacy And Safety Study Of The Combination Chemotherapy With TirapazamineCisplatinVinorelbine Versus CisplatinVinorelbine In Subjects With Inoperable Previously Untreated Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-02
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 It is not yet known if cisplatin and vinorelbine are more effective with or without tirapazamine in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin plus vinorelbine with or without tirapazamine 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 cisplatin plus vinorelbine with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the overall survival duration of patients with stage IIIB or IV non-small cell lung cancer treated with vinorelbine and cisplatin with or without tirapazamine II Compare the complete and partial response rates time to disease progression and time to treatment failure in these patients treated with these regimens III Compare the clinical benefit of these regimens in terms of performance status and body weight in these patients IV Compare the toxicity and safety of these regimens in these patients V Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive tirapazamine IV over 2 hours followed by cisplatin IV over 1 hour on day 1 Patients also receive vinorelbine IV over 6-10 minutes on days 1 8 15 and 22 Arm II Patients receive cisplatin and vinorelbine as in arm I Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline during each course of treatment at 30 days after the last course of treatment and then every 8 weeks for 2-3 years Patients are followed every 8 weeks for 2-3 years
PROJECTED ACCRUAL Approximately 800 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive tirapazamine IV over 2 hours followed by cisplatin IV over 1 hour on day 1 Patients also receive vinorelbine IV over 6-10 minutes on days 1 8 15 and 22 Arm II Patients receive cisplatin and vinorelbine as in arm I Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline during each course of treatment at 30 days after the last course of treatment and then every 8 weeks for 2-3 years Patients are followed every 8 weeks for 2-3 years
PROJECTED ACCRUAL Approximately 800 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 |
|---|---|---|---|
| CDR0000068690 | REGISTRY | PDQ Physician Data Query | None |