Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Study Overview
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Brief Summary
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The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Official Title
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A Phase II Trial to Assess the Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions
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Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
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* Drug: panitumumab + docetaxel + cisplatino


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Inclusion: Age ≥ 18 years Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with advanced unresectable or metastatic disease. Measurable disease per the revised RECIST (Response Evaluation Criteria in Solid Tumor) Guidelines ECOG performance score of 0 - 2 Within seven days prior to initiating study treatment:Haematology:Neutrophils ≥ 1.5x109, Platelets ≥ 100x10/ L, Hemoglobin ≥ 9g/dL. Hepatic functions: Total bilirubin ≤ 1.5 time the upper normal limit (UNL),ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases,ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases. Renal function: creatinine clearance ≥50 mL/min. Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal. Exclusion Criteria: Prior chemotherapy or other anticancer therapy for advanced unresectable or metastatic disease (1st line) Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR inhibitors (e.g. erlotinib). HER2-positive tumor (centrally assessed) Past or current history (within the last 5 years prior to treatment start) of other malignancies except gastric cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) Current or prior history of central nervous system metastases Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study Known hypersensitivity to any of the study drugs Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: panitumumab + docetaxel + cisplatino<br> | Drug: panitumumab + docetaxel + cisplatino<br>* Panitumumab, docetaxel and cisplatin combination treatment will be administered for 6 months or until disease progression (PD) according to investigator's criteria unacceptable toxicity or consent withdrawal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | To estimate the objective response rate in patients treated with docetaxel, cisplatin and panitumumab as first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate |  | 3 years | 
| Duration of response |  | 3 years | 
| Time to response |  | 3 years | 
| Time to progression |  | 3 years | 
| Time to treatment failure |  | 3 years | 
| Duration of stable disease |  | 3 years | 
| Progression free survival |  | 3 years | 
| Overall survival |  | 3 years | 
| Safety profile | To describe the safety profile of this combination therapy in the 1st-line setting including the incidence of AE's and changes in laboratory parameters. | 3 years | 
| Exploratory Objectives | To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints. | 3 years |