Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma (Vecti-BIL)
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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 Endpoint Classification: Safety/Efficacy Study 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 |
- Progression-free survival [ Time Frame: Every 8±1 Weeks until PD ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Objective response rate measured by RECIST, vers.1.1
- Overall survival [ Time Frame: months from randomization to death ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 18 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | March 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:
|
|
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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
-
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| 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: | March 6, 2014 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Fondazione del Piemonte per l'Oncologia:
|
cholangiocarcinoma biliary gallbladder intrahepatic extrahepatic |
Additional relevant MeSH terms:
|
Gemcitabine Oxaliplatin Anti-Infective Agents Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors |
Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015