Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer

August 27, 2014 updated by: Cancer Advances Inc.

Open-Label,Multicenter Study of G17DT Immunogen in Combination w/ Cisplatin and 5-FU in Subjects w/ Metastatic or Locally Recurrent Gastric or Gastroesophageal Cancer Previously Untreated With Chemotherapy.

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

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:

  • Clinical diagnosis with gastric or gastroesophageal cancer
  • Karnofsky performance status score of at least 70
  • Life expectancy of at least 3 months

Exclusion criteria:

  • Prior treatment with chemotherapy or anticancer immunotherapy
  • Bone marrow transplant within past year
  • Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
  • Central nervous system metastases
  • Immunodeficiency
  • Hypercalcemia

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
500µg G17DT administered on Weeks 1, 5 and 9 and an additional treatment at Week 25. Cisplatin was administered every 4 weeks on the first day of each treatment cycle as a 1 to 3 hour intravenous infusion at a dose of 100mg/m^2. 5-FU was administered every 4 weeks during the first 5 days of each cycle as a continuous intravenous infusion at a dose of 1,000 mg/m^2/d.
Biological: Treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.
Time Frame: Through Week 29
Through Week 29

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the clinical efficacy of G17DT in combination with cisplatin and 5-FU chemotherapy as measured by time to disease progression, best overall response and survival.
Time Frame: Through Week 29
Through Week 29

Collaborators and Investigators

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

Sponsor

Cancer Advances Inc.

Investigators

  • Principal Investigator: Jaffer A Ajani, M.D., U.S. studies
  • Principal Investigator: Vladimir Moiseyenko, M.D., Ph.D, Non U.S. studies

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

August 1, 2000

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

July 31, 2002

First Submitted That Met QC Criteria

July 31, 2002

First Posted (Estimate)

August 1, 2002

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC4

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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