Clinical trial NCT00683787 (phase 2, status: terminated)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: docetaxel, vandetanib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H]\C(=C(\[H])C1=CC=C(OC)C=C1)C(=O)OCC(CC)CCCC
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed gastric adenocarcinoma or gastroesophageal junction cancer

               -  Metastatic disease

          -  Measurable disease

          -  No symptomatic CNS metastases

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 3 months

          -  ANC ≥ 1,500/µL

          -  Platelet count ≥ 100,000/µL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Creatinine < 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

          -  Potassium ≥ 4.0 mEq/L (supplementation allowed) and ≤ the CTCAE grade 1 upper limit

          -  Magnesium normal (supplementation allowed) and ≤ the CTCAE grade 1 upper limit

          -  Calcium normal and corrected serum calcium ≤ the CTCAE grade 1 upper limit

               -  In cases where the serum calcium is below the normal range, calcium (adjusted for
                  albumin) normal OR ionized calcium normal

          -  ALT and AST ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for up to 12 weeks after
             completion of study therapy

          -  Atrial fibrillation allowed if controlled by medication

          -  LVEF ≥ 45% by MUGA or ECHO

        Exclusion criteria:

          -  Evidence of severe or uncontrolled systemic disease

          -  Any concurrent condition which makes it undesirable for the patient to participate in
             the trial or which would jeopardize study compliance, in the Investigator's opinion

          -  Uncontrolled infection

          -  Coagulopathy (including warfarin or anti-coagulant related) or bleeding disorder

          -  Peripheral neuropathy ≥ grade 2

          -  Clinically significant cardiac event, including myocardial infarction or New York
             Heart Association class II-IV heart disease within the past 3 months

          -  Presence of cardiac disease that, in the opinion of the Investigator, increases the
             risk of ventricular arrhythmia

          -  History of arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy,
             trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is
             symptomatic or requires treatment (CTCAE grade 3) OR asymptomatic sustained
             ventricular tachycardia

          -  History of QTc prolongation as a result of other medication that required
             discontinuation of that medication

          -  Congenital long QT syndrome or a first degree relative with unexplained sudden death
             under 40 years of age

          -  Presence of left bundle branch block

          -  QTc with Bazett's correction that is unmeasurable or ≥ 480 msec on screening ECG

               -  If a patient has QTc ≥ 480 msec on screening ECG, the screen ECG may be repeated
                  twice (at least 24 hours apart)

               -  The average OTc from the three screening ECGs must be < 480 msec in order for the
                  patient to be eligible for the study

          -  Hypertension not controlled by medical therapy (systolic blood pressure [BP] > 160 mm
             Hg or diastolic BP > 100 mm Hg)

          -  Currently active diarrhea (≥ grade 2) that may affect the ability of the patient to
             absorb vandetanib

          -  Previous or current malignancies of other histologies within the past 5 years, with
             the exception of cervical carcinoma in situ and adequately treated basal cell or
             squamous cell carcinoma of the skin

        PRIOR CONCURRENT THERAPY:

          -  Recovered from all prior therapy

          -  At least 4 weeks since prior chemotherapy or radiotherapy

          -  No more than one prior chemotherapy regimen for metastatic disease

               -  Prior adjuvant therapy, including chemoradiotherapy, allowed

          -  At least 2 weeks since prior palliative radiotherapy

               -  Up to 3750 cGy palliative radiotherapy to the stomach allowed

          -  No prior therapy with docetaxel

          -  More than 30 days since prior investigational agents

          -  More than 4 weeks since prior and no concurrent or planned participation in another
             experimental drug study

          -  More than 4 weeks since prior major surgery and recovered

          -  More than 2 weeks since prior and no concurrent medication that may cause QTc
             prolongation or induce Torsades de Pointes

          -  No concurrent amiodarone

          -  No concurrent potent inducers of CYP3A4 function (e.g., rifampicin, rifabutin,
             phenytoin, carbamazepine, barbiturates, or Hypericum perforatum [St. John wort])

          -  No prior enrollment or randomization to treatment in the present study