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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683787
Recruitment Status : Terminated (low accrual)
First Posted : May 23, 2008
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given together with or without vandetanib.

PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works compared with docetaxel given together with vandetanib in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: docetaxel Drug: vandetanib Phase 2

Detailed Description:



  • To test the hypothesis that the addition of a targeted agent, such as vandetanib, to standard chemotherapy with docetaxel will result in incremental responses in patients with metastatic gastric or gastroesophageal junction cancer.


  • To assess progression-free survival and overall survival of patients treated with this regimen.
  • To study the toxicity profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical site. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive docetaxel IV once every 3 weeks.
  • Arm II: Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
  • Arm III: Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.

In all arms, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months for 5 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Phase II Trial of Docetaxel With/Without VANDETANIB for Advanced Gastroesophageal Cancer
Study Start Date : May 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm I
Patients receive docetaxel IV once every 3 weeks.
Drug: docetaxel
Given IV once every 3 weeks
Experimental: Arm II
Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
Drug: docetaxel
Given IV once every 3 weeks
Drug: vandetanib
Oral vandetanib once daily
Experimental: Arm III
Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
Drug: docetaxel
Given IV once every 3 weeks
Drug: vandetanib
Oral vandetanib once daily

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 3 years ]
  2. Overall Survival [ Time Frame: 3 years ]
  3. Toxicity [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed gastric adenocarcinoma or gastroesophageal junction cancer

    • Metastatic disease
  • Measurable disease
  • No symptomatic CNS metastases


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683787

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Nikhil Khushalani, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00683787     History of Changes
Other Study ID Numbers: CDR0000596150
RPCI-I-106207 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: May 23, 2008    Key Record Dates
Results First Posted: January 8, 2015
Last Update Posted: January 8, 2015
Last Verified: December 2014

Keywords provided by Roswell Park Cancer Institute:
recurrent gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action