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

This study has been terminated.
(results are underpowered as per PI)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00683787
First received: May 21, 2008
Last updated: August 16, 2012
Last verified: September 2011
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: docetaxel
Drug: vandetanib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Phase II Trial of Docetaxel With/Without VANDETANIB for Advanced Gastroesophageal Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: May 2008
Study Completion Date: March 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683787

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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00683787     History of Changes
Other Study ID Numbers: CDR0000596150, RPCI-I-106207
Study First Received: May 21, 2008
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014