Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
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|ClinicalTrials.gov Identifier: NCT00003797|
Recruitment Status : Unknown
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 2, 2003
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: trastuzumab Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Official Title:||Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU|
|Study Start Date :||March 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|