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Home > "G" Clinical Trials Conditions > Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas  Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
For Condition: stage 4A pancreatic cancer,recurrent pancreatic cancer,stage 4B pancreatic cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Brown University
Synopsis: 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.
Details: OBJECTIVES: I. Determine the response rate and survival of patients with metastatic pancreatic cancer and overexpression of HER2-Neu treated with gemcitabine and trastuzumab. II. Determine the toxic effects of this regimen in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven metastatic pancreatic cancer with overexpression of HER-2/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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardSafran, Study Chair, Brown University
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Brown University Oncology Group
Providence, Rhode Island, 02912
United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997
United States
Additional Information:
Study ID Numbers: CDR0000066940; BRUOG-PA-77,NCI-T98-0067
Study Start Date: March 1999
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003797
Other Stage 4a Pancreatic Cancer Studies:
1. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
2. DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
3. Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
4. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
5. Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Related Studies:
Other stage 4A pancreatic cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
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