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

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

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
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 |
Principal Investigator: | Massimo Aglietta, MD | IRCC Candiolo |
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 |