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Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)

NCT00661830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2013-11-21

Study results available
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Summary

This trial will be conducted to evaluate the efficacy, safety and tolerability of a combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong scientific rationale for exploring the role of sorafenib in combination with gemcitabine in advanced CCC.

Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β.

Mutations in these signaling pathways display by far the most common genetic alterations in CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine, suggesting that sorafenib can safely be combined with gemcitabine.

Clinical results of a combination of sorafenib and gemcitabine in a phase I study in pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results together with the knowledge of the molecular pathology of CCC provide a rationale for a randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in advanced CCC.

Conditions

  • Adenocarcinoma

Interventions

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.

DRUG

Placebo

Placebo

DRUG

Sorafenib

Sorafenib 400 mg bid orally continuously

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Interdisciplinary Center for Clinical Trials (IZKS)

    collaborator UNKNOWN

  • PD Dr Markus Möhler

    lead OTHER

Principal Investigators

  • Markus Moehler, MD · Johannes Gutenberg University Mainz, I. Med. Klinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT00661830 on ClinicalTrials.gov