Clinical trial NCT00680901 (phase 3, status: active, not recruiting)
Conditions: neoplasms, gastrointestinal tract
ICD codes: A21.3, A22.2, B46.2, K92.2, K92.81, K91.0, P54.3
Drugs: lapatinib, placebo, capecitabine, oxaliplatin
SMILES: CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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