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
- 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
- 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.
- 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
- 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.