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Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic Cancer

NCT00260364 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-10-14

No results posted yet for this study

Summary

Pancreatic cancer is an aggressive, largely chemo-resistant disease with a poor prognosis. EGFR and VEGF are both overexpressed in pancreatic cancers and thought to contribute to tumour development and progression. The combination of gemcitabine and capecitabine has recently been shown to be effective in advanced pancreatic cancer. The combination of gemcitabine plus erlotinib has also been shown to be effective in advanced pancreatic cancer. The aim of this study is to assess whether combining a chemotherapy doublet (gemcitabine plus capecitabine) and a biologic doublet (erlotinib plus bevacizumab) is a safe and effective way to treat advanced pancreatic cancer by targeting multiple tumour stimulating mechanisms simultaneously.

Conditions

Interventions

DRUG

Gemcitabine 1000 mg/m2 iv days 1, 8, 15 of a 28 day cycle

DRUG

Capecitabine orally days 1 -21

DRUG

Erlotinib 100 mg orally days 1-28

DRUG

Bevacizumab 5 mg/kg intravenously every 2 weeks

Sponsors & Collaborators

  • Professor Cunningham's Clinical Research Fund

    collaborator UNKNOWN

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • David Cunningham, MD, FRCP · The Royal Marsden Hospital NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United Kingdom

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Diseases
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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 NCT00260364 on ClinicalTrials.gov