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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: trastuzumab
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: 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 Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina No prior congestive heart failure No prior myocardial infarction LVEF at least 45% by MUGA or echocardiogram Other: Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior trastuzumab No concurrent growth factors Chemotherapy: 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 Radiotherapy: See Chemotherapy More than 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trastuzumab|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pancreatic cancer, stage IV pancreatic cancer