NCT00042510

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2000

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

July 31, 2002

Last Update Submit

August 27, 2014

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Keywords

Gastroesophageal cancerGastric cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.

    Through Week 29

Secondary Outcomes (1)

  • 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.

    Through Week 29

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

Treatment groupBIOLOGICAL
Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Jaffer A Ajani, M.D.

    U.S. studies

    PRINCIPAL INVESTIGATOR

  • Vladimir Moiseyenko, M.D., Ph.D

    Non U.S. studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2002

First Posted

August 1, 2002

Study Start

August 1, 2000

Primary Completion

February 1, 2003

Study Completion

July 1, 2004

Last Updated

August 28, 2014

Record last verified: 2014-08