Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003881
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Pilot Trial of Carboplatin Paclitaxel and Herceptin in HER2Neu Advanced NSCLC
Status:
COMPLETED
Status Verified Date:
2004-03
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES I Assess the toxicity of monoclonal antibody HER2 with carboplatin and paclitaxel in patients with HER2 positive non-small cell lung cancer II Determine median time to progression and one year freedom from progression in this patient population III Evaluate one year survival rate and overall objective response rate in this patient population
OUTLINE Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on day 1 Patients also receive monoclonal antibody HER2 on days 8 and 15 Treatment is repeated every 3 weeks for 6 courses After 6 courses of treatment patients may receive monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and once a year thereafter until disease progression or death
PROJECTED ACCRUAL A total of 22-44 patients will be accrued for this study
OUTLINE Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on day 1 Patients also receive monoclonal antibody HER2 on days 8 and 15 Treatment is repeated every 3 weeks for 6 courses After 6 courses of treatment patients may receive monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and once a year thereafter until disease progression or death
PROJECTED ACCRUAL A total of 22-44 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 |
|---|---|---|---|
| ECOG-2598 | None | None | None |