Cetuximab + Gemox in Biliary Tract Cancer

NCT01216345 | Completed Phase 2

• 1 other identifier: CCC 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.

Conditions

Unresectable; Locally Advanced; Metastatic

Outcome Measures

Primary Outcomes (1)

• best overall response (according to RECIST 1.0)

  overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded

  after an average of 2 months

Secondary Outcomes (1)

• Safety of the treatment combination

  approximately 6 months

Interventions

Cetuximab + Gemcitabine + Oxaliplatin DRUG

Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks

Also known as: Erbitux, GEMOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer)
• age ≥ 18 years
• ECOG performance status ≤ 2
• bidimensionally measurable disease per RECIST criteria
• no prior chemotherapy or targeted therapy for advanced disease
• adequate bone marrow reserve (neutrophil count \> 1500 /µL, platelet count \> 100,000 /µL)
• adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)
• adequate hepatic function (serum bilirubin \<2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)
• written informed consent

You may not qualify if:

• prior palliative treatment
• resectable disease
• brain metastases
• serious or uncontrolled concurrent medical illness
• pregnancy or nursing
• history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma
• peripheral neuropathy (grade \> 1)

Sponsors & Collaborators

• Association of Research on the Biology of Liver Tumors: lead

Study Sites (1)

KH Rudolfstiftung

Vienna, 1030, Austria

Location

Related Publications (2)

• Gruenberger B, Schueller J, et al: K-ras status and response in patients with advanced or metastatic cholangiocarcinoma treated with cetuximab plus gemcitabine-oxaliplatin (GEMOX): a single center phase II study J Clin Oncol 27:15s, 2009 (suppl; abstr 4586)

  RESULT

• Gruenberger B, Schueller J, Heubrandtner U, Wrba F, Tamandl D, Kaczirek K, Roka R, Freimann-Pircher S, Gruenberger T. Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study. Lancet Oncol. 2010 Dec;11(12):1142-8. doi: 10.1016/S1470-2045(10)70247-3. Epub 2010 Nov 9.

  PMID: 21071270 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Cetuximab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2009
• Last Updated: October 7, 2010

Record last verified: 2010-10

Locations

AU (1)