New York, New York 10021

  • Pancreatic Cancer

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000066940


NCT ID:

NCT00003797


Secondary ID:

BRUOG-PA-77


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

41


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Howard Safran, MD
Study Chair
Brown University

Study Dates

Start Date:March 1999
Verification Date:December 2002
Last Changed Date:December 18, 2013
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:trastuzumab
Intervention Type:Drug
Name:gemcitabine hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brown University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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