Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003797
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
Sponsor:
Brown University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Herceptin NSC 688097 and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2NEU
Status:
UNKNOWN
Status Verified Date:
2002-12
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 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 monoclonal antibody therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2neu
PURPOSE Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2neu
Detailed Description:
OBJECTIVES
Determine the response rate and survival of patients with metastatic pancreatic cancer and overexpression of HER2neu treated with gemcitabine and trastuzumab
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes once weekly during weeks 1-7 Patients receive trastuzumab IV over 90 minutes once during week 1 and trastuzumab IV over 30-90 minutes once weekly during weeks 2-8
Patients with stable or responding disease receive gemcitabine IV over 30 minutes once weekly during weeks 1-3 and trastuzumab IV over 30 minutes once weekly during weeks 1-4 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 41 patients will be accrued for this study over 18-24 months
Determine the response rate and survival of patients with metastatic pancreatic cancer and overexpression of HER2neu treated with gemcitabine and trastuzumab
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes once weekly during weeks 1-7 Patients receive trastuzumab IV over 90 minutes once during week 1 and trastuzumab IV over 30-90 minutes once weekly during weeks 2-8
Patients with stable or responding disease receive gemcitabine IV over 30 minutes once weekly during weeks 1-3 and trastuzumab IV over 30 minutes once weekly during weeks 1-4 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 41 patients will be accrued for this study over 18-24 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 |
|---|---|---|---|
| NCI-T98-0067 | None | None | None |
| BRUOG-PA-77 | None | None | None |