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

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ClinicalTrials.gov Identifier: NCT01389414
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Fondazione del Piemonte per l'Oncologia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Biliary Carcinoma Drug: Panitumumab plus GEMOX chemotherapy Drug: GEMOX chemotherapy Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open-label, Randomized Clinical Trial of Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX) Versus GEMOX Alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma
Study Start Date : May 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A- p-Gemox

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
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.
Other Names:
  • panitumumab: Vectibix
  • Gemcitabine
  • Oxaliplatin

Drug: GEMOX chemotherapy
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.
Other Names:
  • Gemcitabine
  • Oxaliplatin
Active Comparator: Arm B-GEMOX
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
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.
Other Names:
  • Gemcitabine
  • Oxaliplatin


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Every 8±1 Weeks until PD ]
    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.


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Every 8±1 Weeks ]
    Objective response rate measured by RECIST, vers.1.1

  2. Overall survival [ Time Frame: months from randomization to death ]
    Continuosly verified during the treatment period. After the completion of the treatment to be assessed every 3 months by phone contact.

  3. safety [ Time Frame: from the first study drug administration to 28+/-7 days after the last administration ]

    defined as incidence and severity of adverse events, significant laboratory changes, changes in vital signs, incidence of concomitant medications, changes from baseline over time in ECOG PS, incidence of dose adjustments over the treatment period, and incidence of treatment limiting toxicities (TLT) (Any grade 4 or grade 5 toxicity for any adverse event according to the NCTC, ver. 3).

    Continuosly verified during the treatment period. After the completion of the treatment to be assessed at 28+/-7 days after the last administration.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389414


Locations
Italy
Centro di Riferimento Oncologico INT di Aviano
Aviano, Pordenone, Italy, 33081
Ircc Candiolo
Candiolo, Torino, Italy, 10060
AOU S.Luigi Gonzaga
Orbassano, Torino, Italy, 10043
AOU Ospedali Riuniti di Ancona
Ancona, Italy, 60020
UO Oncologia Medica Spedali Civili di Brescia
Brescia, Italy, 25123
I.R.S.T.
Meldola, Italy, 47014
San Raffaele Scientific Institute
Milano, Italy, 20132
Ospedale Niguarda " Ca'-Granda"
Milano, Italy, 20162
Istituto Nazionale per lo studio e la cura dei Tumori-Fondazione Pascale
Napoli, Italy, 80131
SC Oncologia Medica Ospedale S.Maria della Misericordia
Perugia, Italy, 06132
A.O.U S.Giovanni Battista
Torino, Italy, 10126
A.O.U S.Maria della Misericordia
Udine, Italy, 33100
Sponsors and Collaborators
Prof. Massimo Aglietta
Investigators
Principal Investigator: Massimo Aglietta, MD IRCC Candiolo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Massimo Aglietta, Professor, Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT01389414     History of Changes
Other Study ID Numbers: 2009-017428-17
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Prof. Massimo Aglietta, Fondazione del Piemonte per l'Oncologia:
cholangiocarcinoma
biliary
gallbladder
intrahepatic
extrahepatic

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Oxaliplatin
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs