Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
NCT ID: NCT00003797
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
41 participants
INTERVENTIONAL
1999-03-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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trastuzumab
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Brown University
OTHER
Principal Investigators
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Howard Safran, MD
Role: STUDY_CHAIR
Brown University
Locations
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Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States
Brown University Oncology Group
Providence, Rhode Island, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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BRUOG-PA-77
Identifier Type: -
Identifier Source: secondary_id
NCI-T98-0067
Identifier Type: -
Identifier Source: secondary_id
CDR0000066940
Identifier Type: -
Identifier Source: org_study_id