Clinical trial NCT00601510 (phase 1, status: completed)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, cisplatin, imatinib mesylate
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed gastric cancer

               -  Unresectable and/or metastatic disease

          -  Incurable with any conventional multimodality approach by interdisciplinary assessment
             of the local tumor board

          -  Immunohistochemical documentation of c-kit (CD117) and PDGF-R overexpression by tumor
             if obtainable (preferably on a tumor sample taken within 6 weeks of study entry)

          -  At least one evaluable site of disease according to RECIST criteria

          -  No known brain metastasis or CNS disorder that might alter study compliance or may
             worsen during or following therapy

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  WBC ≥ 3,000/μL

          -  ANC ≥ 2,000/μL

          -  Platelet count ≥ 100,000/μL

          -  Hemoglobin ≥ 9.0 g/dL

          -  Total bilirubin < 2 times upper limit of normal (ULN)

          -  SGOT and SGPT < 2.5 times ULN (5 times ULN if hepatic metastases present)

          -  Glomerular filtration rate ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception during and for up to 3
             months after completion of study treatment

          -  No known or documented hypersensitivity against fluoropyrimidines, tyrosine kinase
             inhibitors, cisplatin, other platinums, or their respective derivatives

          -  No gastrointestinal disorder that might affect the gastrointestinal absorption of
             capecitabine or imatinib mesylate or ability to swallow for the oral administration of
             capecitabine or imatinib mesylate

          -  At least 5 years since prior primary malignancy except if the other primary malignancy
             is not currently clinically significant nor requiring active intervention, or if other
             primary malignancy is a basal cell skin cancer or carcinoma in situ of the cervix

          -  No other concurrent malignant disease

          -  No NYHA class III-IV cardiac disease (i.e., congestive heart failure or myocardial
             infarction within the past 6 months)

          -  No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic
             renal disease, or active uncontrolled infection)

          -  No known neuropathy, impaired hearing, history of seizures, and/or psychiatric
             disorder that might alter study compliance or may worsen during or following therapy

          -  No documented dihydropyrimidine dehydrogenase deficiency

          -  No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

          -  No known diagnosis of HIV infection or other serious uncontrolled infections

          -  No significant history of non-compliance to medical regimens or inability to grant
             reliable informed consent

        PRIOR CONCURRENT THERAPY:

          -  No chemotherapy or investigational agents within the past 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) unless the disease is rapidly progressing

          -  No prior radiotherapy to ≥ 25% of the bone marrow

          -  No major surgery within the past 2 weeks

          -  No concurrent warfarin or acetaminophen

               -  Therapeutic anticoagulation using heparin or low-molecular weight heparin allowed

          -  No concurrent sorivudine or related substances

          -  No other concurrent anticancer agents, including chemotherapy and biologic agents

          -  No other concurrent investigational drugs