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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003797
• Other study ID #: CDR0000066940
• Secondary ID: BRUOG-PA-77NCI-T
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: March 1999

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• trastuzumab

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
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	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Brown University Oncology Group	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Roger Williams Medical Center/BUSM	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,