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

Grupo Gallego de Investigaciones Oncologicas9 sites in 1 country55 target enrollmentDecember 2010

ConditionsGastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Interventionspanitumumab + docetaxel + cisplatino

Drugspanitumumab + docetaxel + cisplatino

Overview

Phase: Phase 2
Intervention: panitumumab + docetaxel + cisplatino
Conditions: Gastric Adenocarcinoma
Sponsor: Grupo Gallego de Investigaciones Oncologicas
Enrollment: 55
Locations: 9
Primary Endpoint: Objective response rate
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

December 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Grupo Gallego de Investigaciones Oncologicas

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

panitumumab + docetaxel + cisplatino

Intervention: panitumumab + docetaxel + cisplatino

Outcomes

Primary Outcomes

Objective response rate

Time Frame: 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.