Docetaxel With or Without Vandetanib in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

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