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

NCT01389414 | Completed Phase 2

• 1 other identifier: 2009-017428-17
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Biliary Carcinoma

Keywords

cholangiocarcinoma; biliary; gallbladder; intrahepatic; extrahepatic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival (PFS), defined as the time from randomization to evidence of progression (RECIST, vers.1.1), death, or last radiographic assessment in absence of a PFS event.

  Every 8±1 Weeks until PD

Secondary Outcomes (3)

• Objective response rate

  Every 8±1 Weeks

• Overall survival

  months from randomization to death

• safety

  from the first study drug administration to 28+/-7 days after the last administration

Study Arms (2)

Arm A- p-Gemox

EXPERIMENTAL

Panitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once Q2W. GEMOX chemotherapy will be administered after the administration of panitumumab once Q2W. Gemcitabine 1000mg/sqm will be administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.

Drug: Panitumumab plus GEMOX chemotherapy; Drug: GEMOX chemotherapy

Arm B-GEMOX

ACTIVE COMPARATOR

Gemcitabine 1000mg/sqm will be administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.

Drug: GEMOX chemotherapy

Interventions

Panitumumab plus GEMOX chemotherapy DRUG

panitumumab 6 mg/kg will be administered over 60 minute +/- 15 minutes on day 1 followed by Gemcitabine 1000mg/sqm administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.

Also known as: panitumumab: Vectibix, Gemcitabine, Oxaliplatin

Arm A- p-Gemox

GEMOX chemotherapy DRUG

Gemcitabine 1000mg/sqm will be administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.

Also known as: Gemcitabine, Oxaliplatin

Arm A- p-Gemox; Arm B-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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Massimo Aglietta: lead

Study Sites (12)

AOU Ospedali Riuniti di Ancona

Ancona, Ancona, 60020, Italy

Location

UO Oncologia Medica Spedali Civili di Brescia

Brescia, Brescia, 25123, Italy

Location

I.R.S.T.

Meldola, Meldola, 47014, Italy

Location

San Raffaele Scientific Institute

Milan, Milano, 20132, Italy

Location

Ospedale Niguarda " Ca'-Granda"

Milan, Milano, 20162, Italy

Location

Istituto Nazionale per lo studio e la cura dei Tumori-Fondazione Pascale

Napoli, Napoli, 80131, Italy

Location

SC Oncologia Medica Ospedale S.Maria della Misericordia

Perugia, Perugia, 06132, Italy

Location

Centro di Riferimento Oncologico INT di Aviano

Aviano, Pordenone, 33081, Italy

Location

Ircc Candiolo

Candiolo, Torino, 10060, Italy

Location

AOU S.Luigi Gonzaga

Orbassano, Torino, 10043, Italy

Location

A.O.U S.Giovanni Battista

Torino, Torino, 10126, Italy

Location

A.O.U S.Maria della Misericordia

Udine, Udine, 33100, Italy

Location

Related Publications (1)

• Leone F, Marino D, Cereda S, Filippi R, Belli C, Spadi R, Nasti G, Montano M, Amatu A, Aprile G, Cagnazzo C, Fasola G, Siena S, Ciuffreda L, Reni M, Aglietta M. Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild-type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti-BIL study). Cancer. 2016 Feb 15;122(4):574-81. doi: 10.1002/cncr.29778. Epub 2015 Nov 5.

  PMID: 26540314 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Panitumumab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

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 Officials

• Massimo Aglietta, MD

  IRCC Candiolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 8, 2011
• Study Start: May 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

IT (12)