Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

Summary

This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

Conditions

• Pancreatic Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Intraductal Papillary-Mucinous Neoplasm
• Stage I Pancreatic Cancer AJCC v6 and v7
• Stage II Pancreatic Cancer AJCC v6 and v7

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3-dimensional conformal radiation therapy

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

DRUG

Capecitabine

Given PO

DRUG

Chemotherapy

Given combination chemotherapy

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Erlotinib Hydrochloride

Given PO

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo intensity-modulated radiation therapy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

Sponsors & Collaborators

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Ross A Abrams · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-04-05

Primary Completion

2023-12-10

Completion

2025-09-04

Countries

• United States
• Belgium
• Canada
• Israel

Study Locations