Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Herceptin (NSC #688097) and Gemcitabine for Metastatic Pancreatic Cancers That Overexpress HER-2/NEU
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Howard Safran, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Brown University
Authority:
United States: Federal Government
Study ID:
CDR0000066940
NCT ID:
NCT00003797
Start Date:
March 1999
Completion Date:
Related Keywords:
- Pancreatic Cancer
- recurrent pancreatic cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Mount Sinai Medical Center, NY | New York, New York 10029 |
| New England Medical Center Hospital | Boston, Massachusetts 02111 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Roger Williams Medical Center/BUSM | Providence, Rhode Island 02908-4735 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Brown University Oncology Group | Providence, Rhode Island 02912 |
| St. Elizabeth's Medical Center | Boston, Massachusetts 02135-2997 |
| Memorial Hospital of Rhode Island | Pawtucket, Rhode Island 02860 |
