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

Phase 2

• Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: panitumumab + docetaxel + cisplatino

• Registration Number: NCT01379807
• Lead Sponsor: Grupo Gallego de Investigaciones Oncologicas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2011-04
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-23
• Primary Completion: 2014-12
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
panitumumab + docetaxel + cisplatino	panitumumab + docetaxel + cisplatino	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	3 years
Time to response	3 years
Duration of response	3 years
Time to progression	3 years
Safety profile	3 years	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.
Disease control rate	3 years
Time to treatment failure	3 years
Duration of stable disease	3 years
Overall survival	3 years
Exploratory Objectives	3 years	To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.

Trial Locations

Locations (9)

Complejo Hospitalario Universitario de A Coruña; 🇪🇸 La Coruña, Spain

Hospital de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Arquitecto Mercide; 🇪🇸 Ferrol, La Coruña, Spain

Complejo Hospitalario Ourense; 🇪🇸 Ourense, Spain

Policlínica de Vigo S.A.; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

Complejo Hospitalario Universitario de Vigo (Xeral Cies); 🇪🇸 Vigo, Pontevedra, Spain

Complejo Hospitalario Universitario de Santiago (CHUS); 🇪🇸 Santiago de Compostela, La Coruña, Spain

Centro Oncológico de Galícia; 🇪🇸 La Coruña, Spain