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Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

NCT00440167 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2012-07-09

No results posted yet for this study

Summary

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28

DRUG

Capecitabine

Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")

DRUG

Erlotinib

Erlotinib 150 mg/d oral, daily without break

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • PD Dr. med. Volker Heinemann

    lead OTHER

Principal Investigators

  • Volker Heinemann, MD · University of Munich - Klinikum Grosshadern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-12-31
Completion
2012-12-31

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Entities

Drugs
Diseases

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 NCT00440167 on ClinicalTrials.gov