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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
000161
NCT00005926
June 2000
December 2000
Name | Location |
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National Cancer Institute (NCI) | Bethesda, Maryland 20892 |