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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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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 CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Rhode Island HospitalProvidence, Rhode Island  02903
Mount Sinai Medical Center, NYNew York, New York  10029
New England Medical Center HospitalBoston, Massachusetts  02111
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Roger Williams Medical Center/BUSMProvidence, Rhode Island  02908-4735
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Brown University Oncology GroupProvidence, Rhode Island  02912
St. Elizabeth's Medical CenterBoston, Massachusetts  02135-2997
Memorial Hospital of Rhode IslandPawtucket, Rhode Island  02860