Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

April 8, 2013 updated by: Samsung Medical Center

Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum

The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
  2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
  3. prior chemotherapy wit fluoropyrimidine and platinum
  4. measurable or evaluable disease according to RECIST
  5. age, 18 years or older
  6. ECOG performance status 0 - 2
  7. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL
  8. life expectancy of ≥ 3 months
  9. signed written informed consent

Exclusion Criteria:

  1. more than one prior chemotherapy for metastatic disease
  2. severe co-morbid illness and/or active infections
  3. NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment
  4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
  5. pregnant or lactating women
  6. active CNS metastases not controllable with radiotherapy or corticosteroids
  7. active and uncontrollable bleeding from gastrointestinal tract
  8. known history of hypersensitivity to study drugs
  9. prior treatment with sunitinib

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel + Sunitinib
Docetaxel and Sunitinib
Drug: Docetaxel + Sunitinib

Docetaxel 60 mg/m2 iv, every 3 weeks

Sunitinib 37.5 mg qd daily, every 3 weeks
Active Comparator: Docetaxel
Docetaxel only
Drug: Docetaxel only
Docetaxel 60 mg/m2 iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to progression
Time Frame: every 6 weeks
every 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 12 months
12 months
Overall survival
Time Frame: 12 months
12 months
Response rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-09-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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