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

Grupo Gallego de Investigaciones Oncologicas

Status and phase

Unknown

Phase 2

Conditions

Gastroesophageal Junction Adenocarcinoma

Gastric Adenocarcinoma

Treatments

Drug: panitumumab + docetaxel + cisplatino

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01379807

GGIO-2010-01

Details and patient eligibility

About

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.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.