NCT00552149 is a Phase 2 clinical trial of Gemox, Cetuximab in Advanced Biliary Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris.

Who is sponsoring NCT00552149?

NCT00552149 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris.

What drugs are being tested in NCT00552149?

Interventions in NCT00552149: Gemox, Cetuximab.

What condition does NCT00552149 study?

NCT00552149 studies Advanced Biliary Cancer.

Is NCT00552149 still recruiting?

NCT00552149 is currently completed. Last updated 12 June 2012.

Last reviewed 2012-06-12 · How we verify

NCT00552149

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination With Cetuximab in Patients With Advanced Biliary Cancer.

Completed Phase 2 Last updated 12 June 2012

What this trial tests

Phase 2 trial testing Gemox, Cetuximab in Advanced Biliary Cancer in 150 participants. Completed in 1 April 2012.

Timeline

1 October 2007

Primary endpoint
1 April 2012

1 April 2012

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 October 2007
Primary completion	1 April 2012
Estimated completion	1 April 2012
Sites	1 location across France

Drugs / interventions tested

Gemox, Cetuximab — full drug profile →

Conditions studied

Advanced Biliary Cancer — all drugs for Advanced Biliary Cancer →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Biliary Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months
Time frame: 4 months

Sponsor's own description

A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial.
Malka D, Cervera P, Foulon S, Trarbach T, et al · · 2014 · cited 300× · PMID 24852116 · DOI 10.1016/s1470-2045(14)70212-8
Latest evidence on immunotherapy for cholangiocarcinoma.
Guo X, Shen W. · · 2020 · cited 26× · PMID 33154779 · DOI 10.3892/ol.2020.12244
Promising Molecular Targets for the Targeted Therapy of Biliary Tract Cancers: An Overview.
Yang W, Sun Y. · · 2021 · cited 17× · PMID 33658799 · DOI 10.2147/ott.s297643
EGFR Target Therapy Combined with Gemox for Advanced Biliary Tract Cancers: a Meta-analysis based on RCTs.
Cai W, Yuan Y, Ge W, Fan Y, et al · · 2018 · cited 14× · PMID 29721058 · DOI 10.7150/jca.23290
Current Standards, Multidisciplinary Approaches, and Future Directions in the Management of Extrahepatic Cholangiocarcinoma.
Wheless M, Agarwal R, Goff L, Lockney N, et al · · 2024 · cited 13× · PMID 38177560 · DOI 10.1007/s11864-023-01153-5
Biomarkers and Management of Cholangiocarcinoma: Unveiling New Horizons for Precision Therapy.
Nishida N. · · 2025 · cited 7× · PMID 40227772 · DOI 10.3390/cancers17071243
Targeted medical therapy of biliary tract cancer: recent advances and future perspectives.
Hopfner M, Schuppan D, Scherubl H. · · 2008 · cited 6× · PMID 19084910 · DOI 10.3748/wjg.14.7021
Systemic review of the robustness of randomized controlled trials for the treatment of cholangiocarcinoma in three domains: survival-inferred fragility index, restricted mean survival time, and the spin effect.
Horesh N, Bomze D, Lim C, Markel G, et al · · 2022 · cited 5× · PMID 36523938 · DOI 10.21037/hbsn-21-118

Verify or expand the search:

Other Gustave Roussy, Cancer Campus, Grand Paris trials

Trials by the same sponsor.

NCT07303387 — Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors. · Phase 2 · not yet recruiting
NCT07159451 — A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovaria · Phase 2 · recruiting
NCT06781996 — A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuva · Phase 3 · recruiting
NCT07016230 — Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and · Phase 2 · recruiting
NCT06902883 — Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00552149 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris
Last refreshed: 12 June 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00552149.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing