Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
Recruitment status was: Active, not recruiting
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 HER2/neu.
|Pancreatic Cancer||Biological: trastuzumab Drug: gemcitabine hydrochloride||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU|
|Study Start Date:||March 1999|
- Determine the response rate and survival of patients with metastatic pancreatic cancer and overexpression of HER2/neu 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003797
|United States, Illinois|
|Rush-Presbyterian-St. Luke's Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States, 02111|
|St. Elizabeth's Medical Center|
|Boston, Massachusetts, United States, 02135-2997|
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|United States, Rhode Island|
|Memorial Hospital of Rhode Island|
|Pawtucket, Rhode Island, United States, 02860|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Roger Williams Medical Center/BUSM|
|Providence, Rhode Island, United States, 02908-4735|
|Brown University Oncology Group|
|Providence, Rhode Island, United States, 02912|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Howard Safran, MD||Brown University|