Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005838
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multicenter Open-Ended Double-Blind Placebo-Controlled Phase III Study of AE-941 in Addition to Combined Modality Treatment ChemotherapyRadiotherapy for Locally Advanced Unresectable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
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 Radiation therapy uses high-energy x-rays to damage tumor cells AE-941 may help shrink or slow the growth of non-small cell lung cancer cells It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without AE-941 for non-small cell lung cancer This randomized phase III trial is studying combination chemotherapy and radiation therapy given with AE-941 to see how well they work compared to combination chemotherapy and radiation therapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I Determine the overall survival of patients with unresectable stage IIIA or IIIB non-small cell lung cancer treated with induction platinum-based chemotherapy and radiotherapy with or without AE-941 Neovastat
II Determine the progression-free survival tumor response tumor response duration and metastasis-free survival of patients treated with these regimens
III Determine the tolerability of this regimen in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to stage IIIA vs IIIB type of platinum-based induction chemotherapy to be received cisplatin and vinorelbine vs carboplatin and paclitaxel and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral AE-941 Neovastat twice daily beginning on day 1 or within 10 days of initiation of chemotherapy
Arm II Patients receive oral placebo twice daily beginning on day 1 or within 10 days of initiation of chemotherapy
All patients receive induction chemotherapy with 1 of the following platinum-based regimens cisplatin IV on days 1 22 50 and 71 and vinorelbine IV on days 1 8 22 29 50 57 71 and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1 22 50 57 64 71 78 and 85
All patients receive radiotherapy beginning on day 50 for 6 weeks Treatment in both arms continues in the absence of unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 756 patients 378 per treatment arm will be accrued for this study within 36 months
I Determine the overall survival of patients with unresectable stage IIIA or IIIB non-small cell lung cancer treated with induction platinum-based chemotherapy and radiotherapy with or without AE-941 Neovastat
II Determine the progression-free survival tumor response tumor response duration and metastasis-free survival of patients treated with these regimens
III Determine the tolerability of this regimen in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to stage IIIA vs IIIB type of platinum-based induction chemotherapy to be received cisplatin and vinorelbine vs carboplatin and paclitaxel and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral AE-941 Neovastat twice daily beginning on day 1 or within 10 days of initiation of chemotherapy
Arm II Patients receive oral placebo twice daily beginning on day 1 or within 10 days of initiation of chemotherapy
All patients receive induction chemotherapy with 1 of the following platinum-based regimens cisplatin IV on days 1 22 50 and 71 and vinorelbine IV on days 1 8 22 29 50 57 71 and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1 22 50 57 64 71 78 and 85
All patients receive radiotherapy beginning on day 50 for 6 weeks Treatment in both arms continues in the absence of unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 756 patients 378 per treatment arm will be accrued for this study within 36 months
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 |
|---|---|---|---|
| ID99-303 | None | None | None |
| U10CA045809 | NIH | None | None |
| CDR0000067853 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA045809 |