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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trastuzumab
gemcitabine hydrochloride
Sponsored by
Brown University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush-Presbyterian-St. Luke's Medical Center
  • New England Medical Center Hospital
  • St. Elizabeth's Medical Center
  • Cancer Institute of New Jersey
  • Memorial Sloan-Kettering Cancer Center
  • Mount Sinai Medical Center, NY
  • University of Pittsburgh Cancer Institute
  • Memorial Hospital of Rhode Island
  • Rhode Island Hospital
  • Roger Williams Medical Center/BUSM
  • Brown University Oncology Group
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
Brown University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003797
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Unknown status
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Brown University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
trastuzumab
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Safran, MD
Organizational Affiliation
Brown University
Official's Role
Study Chair
Facility Information:
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135-2997
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3489
Country
United States
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Roger Williams Medical Center/BUSM
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4735
Country
United States
Facility Name
Brown University Oncology Group
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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

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