LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Inclusion Criteria:

Signed informed consent; Histologically confirmed gastric, esophageal, or gastro-esophageal
junction adenocarcinoma; disease that is locally advanced (unresectable), metastatic, or
locally recurrent disease; Measurable or non-measurable, but radiologically evaluable
disease, according to RECIST; ErbB2 (HER2)positive; Age =18 years; ECOG Performance status
= 2; Adequate organ function, including adequate hematologic, renal and liver function;
Cardiac ejection fraction within institutional range of normal as measured by
echocardiogram; Able to swallow and retain oral medications, and/or receive enteral
medications via gastrectomy feeding tube; Women and men with potential to have children
must be willing to practice acceptable methods of birth control during the study; Prior
gastric surgery is permitted if > 3 weeks prior and recovered; Prior chemotherapy for
non-gastric malignancy if > than 5 years; Prior neoadjuvant and/or adjuvant chemotherapy
for early stage gastric cancer if > 6 months since completion; At least 4 weeks since prior
radiotherapy; Prior biologic, hormonal, or immunologic cancer treatment if > 5 years since
treatment.

Exclusion Criteria:

Pregnant or lactating females; Known history of active CNS disease; Uncontrolled ascites;
Concurrent anti-cancer therapy; Gastric carcinoid, epidermoid, sarcomas, or squamous cell
carcinoma; Prior palliative chemotherapy for the treatment of gastric cancer; Prior
treatment with oxaliplatin < 12 months; Malabsorption syndrome or uncontrolled inflammatory
gastrointestinal disease; Known history of uncontrolled or symptomatic angina, arrhythmias,
or congestive heart failure; Pre-existing grade = 2 motor or sensory neuropathy;
Uncontrolled infection; Concurrent disease or condition that would make the subject
inappropriate for study participation or any serious medical condition that would interfere
with the subject''s safety; Active hepatic or biliary disease; History of other malignancy
except if disease-free for 5 years, a history of completely resected non-melanoma skin
cancer, or a successfully treated in situ carcinoma; Unresolved or unstable serious
toxicity from prior administration of another investigational drug and/or prior cancer
treatment; Dementia, altered mental status, or any psychiatric condition that would
prohibit the understanding or rendering of informed consent; Known history of DPD
deficiency; Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients;
Use of any investigational drug within 30 days prior randomization; Use of concurrent
prohibited medications that would interact with study medications