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A Phase II Trial of Gemcitabine, Herceptin, and Radiation for Regionally Confined Adenocarcinoma of the Pancreas

Phase 2
Not Enrolling
Pancreatic Cancer, Pancreatic Neoplasm

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Trial Information

A Phase II Trial of Gemcitabine, Herceptin, and Radiation for Regionally Confined Adenocarcinoma of the Pancreas

This is a phase II study of gemcitabine and Herceptin given weekly as a bolus infusion
administered concurrently with radiotherapy in patients with regionally confined resectable
or unresectable adenocarcinoma of the pancreas that overexpress HER2. Patients will be
treated with external beam radiation in a standard manner over 6 weeks prior to surgical
exploration. Gemcitabine and Herceptin will be administered on the first day of irradiation
and weekly during the course of radiotherapy. Patients will be assessed for resectability
after treatment and may undergo a pancreatic resection. Patients will then be treated with
once weekly gemcitabine and herceptin for three weeks followed by 1 week of rest for up to 6
months. Patients will be assessed clinically for toxicity, tumor response, progression-free
survival, and overall survival.

Inclusion Criteria

Patients must have regionally confined histologically or cytologically proven
adenocarcinoma of the pancreas or Ampulla of Vater. Tumors must overexpress HER2 as
demonstrated by greater than or equal to 2+ immunohistochemical staining of the biopsy

Patients must sign an informed consent.

Patients must have an ECOG performance status of less than or equal to 2.

Patients should have a serum creatinine less than 1.5 mg/dl or creatinine clearance
greater than 60 ml/hr; SGOT and SGPT less than 4 times the upper limit of normal.

Patients must have an ANC greater than 2000/mm(3) and platelets greater than

Patients must be at least 18 years of age.

Patients of all racial and gender groups will be included.

Patients must not have received any prior gemcitabine, radiotherapy, or Herceptin therapy
for pancreatic cancer.

Patients cannot receive concurrent hormonal or immunotherapy treatment for pancreatic

Patients cannot receive any anti-tumor therapy within 30 days of protocol eligibility and
must have recovered from any prior treatment related toxicity.

Patients must not have evidence of distant metastases (e.g., peritoneal, carcinomatosis,
liver metastases).

No concurrent second malignancy other than non-melanoma skin cancer or cervical carcinoma
in situ.

Must not have medical conditions that preclude undergoing surgery or receiving therapy or
follow up, or have psychiatric disease which would prevent adequate informed consent or
render receiving this therapy unsafe.

No patients with an LV ejection fraction less than the lower limit of normal as determined
at the Clinical Center, NIH.

Women must not be pregnant or nursing due to the unknown effects of this therapy on the
unborn or nursing child.

Must not have received prior abdominal or pelvic radiation.

Must not have recent myocardial infarction (less than 6 months prior), unstable angina, or
congestive heart failure (NYHA class III or IV).

Must not have active diseases which make the patient more susceptible to infection,
including but not limited to AIDS, hepatitis, history of autoimmune disorders, because the
experimental treatment being evaluated in this protocol may be unsafe in the absence of an
intact immune system.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

December 2000

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasm
  • Cancer
  • Gemzar
  • Her-2/Neu
  • Pancreatic
  • Radiotherapy
  • Pancreatic Cancer
  • Neoplasms
  • Pancreatic Neoplasms



National Cancer Institute (NCI) Bethesda, Maryland  20892