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Phase I Study of Gemcitabine, Sorafenib and Radiotherapy in Patients With Unresectable Pancreatic Cancer

NCT00375310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-02-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of the combined treatment of Sorafenib (BAY 43-9006) with Gemcitabine and radiotherapy in patients with localized unresectable pancreatic cancer.

Conditions

Interventions

DRUG

Gemcitabine, Sorafenib

Gemcitabine is given IV Sorafenib is given orally of varying doses: 1. Sorafenib 200 mg po qd ( during combination therapy) 2. Sorafenib 400 mg po qd ( during combination therapy) 3. Sorafenib 400 mg po bid ( during combination therapy)

PROCEDURE

Radiotherapy

1.8 Gy CTV daily for 5 weeks

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Romnee Clark, MD · IU Simon Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375310 on ClinicalTrials.gov