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

NCT00683787 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000596150RPCI-I-106207
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

recurrent gastric cancer; stage IV gastric cancer; adenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  1 year

Secondary Outcomes (3)

• Progression-free Survival

  3 years

• Overall Survival

  3 years

• Toxicity

  1 year

Study Arms (3)

Arm I

ACTIVE COMPARATOR

Patients receive docetaxel IV once every 3 weeks.

Drug: docetaxel

Arm II

EXPERIMENTAL

Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.

Drug: docetaxel; Drug: vandetanib

Arm III

EXPERIMENTAL

Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.

Drug: docetaxel; Drug: vandetanib

Interventions

docetaxel DRUG

Given IV once every 3 weeks

Arm I; Arm II; Arm III

vandetanib DRUG

Oral vandetanib once daily

Arm II; Arm III

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; vandetanib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Nikhil Khushalani, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: March 1, 2011
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2014-12

Locations

US (1)