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Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer

NCT01308840 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-08-17

Study results available
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Summary

The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population.

Conditions

  • Biliary Tract Cancer
  • Gallbladder Cancer

Interventions

DRUG

Panitumumab

Day 1 and 15 = 6 mg/kg IV

DRUG

oxaliplatin

Days 1 and 15 = 85mg/m2 IV

DRUG

gemcitabine

Days 1 and 15 = 1000 mg/m2 IV

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • University of Rochester

    lead OTHER

Principal Investigators

  • Aram Hezel, MD · University of Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01308840 on ClinicalTrials.gov