Clinical trial NCT00253370 (phase 2, status: completed)
Conditions: adenocarcinoma of the gastroesophageal junction, metastatic gastric cancer, advanced unresectable gastric cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123
Drugs: bay 43-9006, docetaxel, cisplatin
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, [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
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have measurable, histologically confirmed, advanced unresectable or
             metastatic gastric or GEJ adenocarcinoma; imaging studies must be conducted within 4
             weeks of study entry

          -  For patients with GEJ adenocarcinoma, the tumor location should be specified using the
             Siewert classification used in other NCI-sponsored Phase II studies in these disease
             sites

          -  Patients must have an ECOG performance status of 0-1

          -  Patients may have had adjuvant chemotherapy or chemoradiation therapy, with or without
             5-Fluorouracil if the treatment was performed more than 6 months before any evidence
             of recurrent or metastatic disease

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Must have the following baseline laboratory values obtained within 2 weeks of
             registration:

               -  Absolute Granulocyte Count >= 1,500/mm^3

               -  Platelet Count >= 100,000/mm^3

               -  White Blood Count >= 3,000/mm^3

               -  Serum Creatinine <= 1.5 mg/dl

               -  Total Bilirubin <= 2.0 mg/dl

               -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline
                  phosphatase (Alk phos) <= 2.5 x upper limit of normal

          -  Patients must be able to take oral medication without crushing, dissolving or chewing
             tablets

        Exclusion Criteria:

          -  Prior radiotherapy, chemotherapy or investigational therapies, particularly inhibitors
             of tyrosine Kinases, signal transduction or angiogenesis in the treatment for their
             recurrent and/or metastatic gastric or GEJ adenocarcinoma

          -  Receiving any other investigational agents

          -  Being pregnant or breast-feeding; all females of childbearing potential must have a
             blood or urine test within 2 weeks prior to registration to rule out pregnancy

          -  HIV-positive patients receiving combination antiretroviral therapy are excluded from
             the study because of possible pharmacokinetic interactions with BAY 43-9006

          -  Brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to BAY 43-9006

          -  Acute active infection with significant clinical intervention per physician's
             discretion

          -  Previous or concurrent malignancies are not allowed, except:

               -  Non-melanoma skin cancer and in situ cervical cancer

               -  Treated cancer from which the patient has been continuously disease-free for more
                  than five years

          -  Other uncontrolled intercurrent illnesses including, but not limited to: uncontrolled
             hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia or psychiatric illness/addictive disorders that would limit compliance with
             study requirements

          -  Evidence of bleeding diathesis

          -  Concurrent cytochrome P450 enzyme-inducing anti-epileptic drugs:

               -  Phenytoin

               -  Carbamazepine

               -  Phenobarbital

               -  Rifampin

               -  St. John's Wort