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

Phase 2

Terminated

• Conditions: Gastric Cancer
• Interventions: Drug: docetaxel; Drug: vandetanib

• Registration Number: NCT00683787
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-23
• Primary Completion: 2009-04
• Study Completion: 2011-03
• Results First Submitted: 2014-05-12
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Results First Posted: 2015-01-08
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	1 year

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	3 years
Overall Survival	3 years
Toxicity	1 year

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States