Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Massimo Aglietta
• Treatments: Antibodies, Monoclonal; Gemcitabine; Oxaliplatin; Panitumumab

Criteria

Inclusion Criteria:

• Histologically or cytologically documented surgically unresectable or metastatic biliary tract adenocarcinoma (KRAS wild-type) including gallbladder either at diagnosis or relapsing after surgery.

• Documented KRAS status either on primary tumor or metastasis. KRAS testing will be performed as per center procedure (no centralized analysis is required).

• Availability of a tumor biopsy for the study of tumor biomarkers potentially involved in the response/resistance mechanisms.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

• Estimated life expectancy of at least 3 months.

• Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy, defined as:

• absolute neutrophil count (ANC) ≥ 1.5 x 10E9 cells/L

• platelet count ≥ 100 x 10E9 cells/L

• total hemoglobin > 9.0 g/dL

• total bilirubin < 2.0 x institutional upper limit of normal (ULN)

• alanine aminotransferase (ALT), aspartate transaminase (AST) < 2.5 x ULN - alkaline phosphatase < 3.0 x ULN

• creatinine < 1.5 X ULN

• magnesium ≥ LLN

• calcium ≥ LLN

• Voluntary, written and dated informed consent.

Exclusion Criteria:

• Any previous chemotherapy or target therapy .

• Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.

• Coexisting malignancies, except for basal or squamous cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.