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Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma (Vecti-BIL)
This study has been completed.
Sponsor:
Prof. Massimo Aglietta
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier:
NCT01389414
First received: July 1, 2011
Last updated: May 27, 2015
Last verified: May 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Biliary Carcinoma | Drug: Panitumumab plus GEMOX chemotherapy Drug: GEMOX chemotherapy | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Prof. Massimo Aglietta, Fondazione del Piemonte per l'Oncologia:
Primary Outcome Measures:
- 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:
- 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.
| Enrollment: | 89 |
| Study Start Date: | May 2010 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01389414
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | July 1, 2011 |
| Last Updated: | May 27, 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 |
ClinicalTrials.gov processed this record on June 23, 2017