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Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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 HER2/neu.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: trastuzumab Drug: gemcitabine hydrochloride Phase 2

Detailed Description:


  • 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
Primary Purpose: Treatment
Official Title: Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU
Study Start Date : March 1999

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven metastatic pancreatic cancer with overexpression of HER2/neu
  • Patients in whom there is inadequate tissue to evaluate for HER2/neu overexpression but who have elevated serum HER2/neu antigen levels are eligible
  • Radiographically measurable disease

    • May have metastatic disease in which primary lesion is measurable but metastatic lesions are not measurable
    • Ascites is not measurable



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 3.0 mg/dL

    • Greater than 3 times normal if increase in bilirubin is due to biliary obstruction from tumor as long as biliary system is stented or bypassed and bilirubin, SGOT, or SGPT is stable or decreasing
  • SGOT no greater than 3 times normal

    • No greater than 5 times normal if liver metastases present OR
    • Greater than 5 times normal if increase in SGOT or SGPT is due to biliary obstruction from tumor as long as biliary system is stented or bypassed and biliary SGOT or SGPT is stable or decreasing


  • Creatinine no greater than 2.0 mg/dL


  • No unstable angina
  • No prior congestive heart failure
  • No prior myocardial infarction
  • LVEF at least 45% by MUGA or echocardiogram


  • Not pregnant
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior trastuzumab
  • No concurrent growth factors


  • No prior anthracyclines
  • No prior gemcitabine except prior low dose (no greater than 300 mg/m2/week) gemcitabine with radiotherapy
  • At least 6 months since prior adjuvant therapy
  • More than 2 weeks since other prior chemotherapy
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • Not specified


  • See Chemotherapy
  • More than 2 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • No other concurrent investigational agents

Information from the National Library of Medicine

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
Sponsors and Collaborators
Brown University
National Cancer Institute (NCI)
Study Chair: Howard Safran, MD Brown University

ClinicalTrials.gov Identifier: NCT00003797     History of Changes
Other Study ID Numbers: CDR0000066940
First Posted: May 2, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2002

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs