A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib
A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.
Key inclusion criteria:
Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease.
Measurable or non-measurable, but radiologically evaluable disease, according to RECIST.
HER2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown HER2 status were not eligible.
Adequate organ function, as defined in the study protocol, assessed within 14 days prior randomization.
Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO).
Prior/Concurrent Therapy:
Key exclusion criteria:
Ciudad Aut6noma de Buenos Aires, Buenos Aires C1050AAK, Argentina
Pokfulam, Hong Kong
Zrifin, 70300, Israel
Pesasro, The Marches 61122, Italy
Taoyuan County, 333, Taiwan
Hatyai, Songkhla, 90110, Thailand
Plyuty, 08720, Ukraine
Simferopil, 95023, Ukraine
Vinnitsia, 21029, Ukraine