Phase II., non randomized, open study: inoperable gall bladder or biliary tract EGFR expressing carcinoma treatment with Erbitux and 5-fluorouracil, epiadriamycin, mitomycin containing combination

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004981-14-HU

Enrollment

Registered

2006-10-03

Start date

2006-12-20

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irresectable biliary tract cancer where palliation is the aim. It could be locally extanded and also metastatic cancer

Interventions

Trade Name: Erbitux Product Name: cetuximab Pharmaceutical Form: Solution for infusion Trade Name: Erbitux Product Name: cetuximab Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed informed concent. Age over 18years. Histologically proven gall bladder or biliary tract cancer not suitable to surgery. EGFR positivity (IHC). ECOG 0-2. Adequate cardiac, renal and hepatic function. Measurable lesion (RECIST 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Bad general condition: ECOG 3-4. Congestiv heart failure (NYHA 2-4) or major arrhytmia. White blood count under 3 G/l, platelet under 100 G/l. Kreatinin more that 2x UNL, ALP/AST more than 5x UNL. Known hyperreactivity to any trial drug. Pregnency.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective to investigate response rate,;Secondary Objective: secondary objectives are PFS, OS and safety.;Primary end point(s): Response rate;Timepoint(s) of evaluation of this end point: Every 8-12 weeks during treatment until progression	—

Secondary

Measure	Time frame
Secondary end point(s): Progression free survival, overall survival, safety/adverse events;Timepoint(s) of evaluation of this end point: PFS: radiologically proven or clinical progression. OS: time of death. Safety: every visit.	—

Countries

Hungary

Contacts

Public ContactDept. of Clinical Oncology "B"

National Institute of Oncology

36122486003442

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026