Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016367
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2001-05-06
Brief Title:
Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Multidose Single Arm Multicenter Clinical Trial of Cisplatin and Gemcitabine in Combination With Recombinant Humanized Anti-p185HER2 Monoclonal Antibody Herceptin in Patients Who Have Untreated p185HER2 Overexpressing Advanced Local Stage Stage IIIb Pleural Effusion Only and Metastatic Stage IV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
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 Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE Phase II trial to study effectiveness of combining cisplatin gemcitabine and trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study effectiveness of combining cisplatin gemcitabine and trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the therapeutic efficacy and toxicity of cisplatin gemcitabine and trastuzumab Herceptin in patients with untreated p185-HER2 overexpressing stage IIIB or IV non-small cell lung cancer II Determine the pharmacokinetic interactions among these drugs in these patients III Assess the pharmacodynamics of these drugs in these patients
OUTLINE This is a multicenter study Regimen A Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab Herceptin IV over 90 minutes on day 2 Patients receive trastuzumab IV over 90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15 Patients proceed to regimen B on day 22 of regimen A Regimen B Patients receive trastuzumab IV over 30-90 minutes gemcitabine IV over 30 minutes and cisplatin IV over 2 hours on day 1 Patients receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 30-90 minutes on day 15 Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity Maintenance After completion of 6 courses patients with stable disease or partial response receive trastuzumab IV over 30-90 minutes weekly until tumor progression
PROJECTED ACCRUAL A total of 20-48 patients will be accrued for this study
OUTLINE This is a multicenter study Regimen A Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab Herceptin IV over 90 minutes on day 2 Patients receive trastuzumab IV over 90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15 Patients proceed to regimen B on day 22 of regimen A Regimen B Patients receive trastuzumab IV over 30-90 minutes gemcitabine IV over 30 minutes and cisplatin IV over 2 hours on day 1 Patients receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 30-90 minutes on day 15 Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity Maintenance After completion of 6 courses patients with stable disease or partial response receive trastuzumab IV over 30-90 minutes weekly until tumor progression
PROJECTED ACCRUAL A total of 20-48 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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-DM-99015 | OTHER | None | None |
| NCI-4450 | None | None | None |
| CDR0000068626 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |