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NCT00982592 · ClinicalTrials.gov registry record · Phase 2

Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer

A Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Stage IV Gastric Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
124
Enrollment target
20
Study locations

NCT00982592: Completed Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Stage IV Gastric Cancer, sponsored by National Cancer Institute (NCI).

NCT00982592 is a Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Stage IV Gastric Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 124 participants, above the 75-participant average among 7 other Adenocarcinoma of the Gastroesophageal Junction trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00982592, a Phase 2 study of Adenocarcinoma of the Gastroesophageal Junction and Stage IV Gastric Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
124 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase II trial studies combination chemotherapy when given together with vismodegib to see how well it works compared with combination chemotherapy without vismodegib in treating patients with advanced stomach cancer or gastroesophageal junction cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Vismodegib may stop the growth of stomach or gastroesophageal junction cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether combination chemotherapy is more effective when given with or without vismodegib in treating stomach cancer and gastroesophageal junction cancer.

Primary Outcome

PFS is defined as the time from randomization until objective tumor progression or death from any cause and is evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Conditions Studied

Adenocarcinoma of the Gastroesophageal Junction Stage IV Gastric Cancer Recurrent Gastric Cancer Stage IIIB Gastric Cancer Adenocarcinoma of the Stomach Stage IIIA Gastric Cancer Stage IIIC Gastric Cancer

Interventions

  • OTHER placebo
  • DRUG oxaliplatin
  • DRUG fluorouracil
  • DRUG leucovorin calcium
  • DRUG vismodegib

Study Locations (20)

Illinois

  • University of Chicago - Chicago
  • Cancer Care Center of Decatur - Decatur
  • Decatur Memorial Hospital - Decatur
  • Crossroads Cancer Center - Effingham
  • NorthShore University HealthSystem-Evanston Hospital - Evanston
  • Ingalls Memorial Hospital - Harvey
  • Loyola University Medical Center - Maywood
  • Illinois CancerCare-Peoria - Peoria
  • Illinois Oncology Research Association CCOP - Peoria
  • Memorial Medical Center - Springfield

New York

  • Beth Israel Medical Center - New York
  • New York University Langone Medical Center - New York
  • Saint Luke's Roosevelt Hospital Center - Saint Luke's Division - New York
  • Columbia University Medical Center - New York

Indiana

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview - Fort Wayne
  • Indiana University Medical Center - Indianapolis

Michigan

  • University of Michigan University Hospital - Ann Arbor
  • University of Michigan - Ann Arbor

California

  • University of California at Davis Cancer Center - Sacramento

Missouri

  • Saint John's Mercy Medical Center - St Louis

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2009-09
Est. Completion 2014-10
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00982592 record still lists

NCT00982592 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 7 other Adenocarcinoma of the Gastroesophageal Junction trials with a reported enrollment target (65% higher).

The record links to 7 conditions, with Adenocarcinoma of the Gastroesophageal Junction appearing as the primary indexed condition, and to 5 interventions - of which placebo is the first listed.

NCT00982592 names 20 study sites across 6 states, led by Illinois, New York, Indiana.

Frequently Asked Questions

What is clinical trial NCT00982592 about?

NCT00982592 is a clinical study titled "Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer". This randomized phase II trial studies combination chemotherapy when given together with vismodegib to see how well it works compared with combination chemotherapy without vismodegib in treating patients with advanced stomach cancer or gastroesophageal junction cancer. Drugs used in chemotherapy, su...

What is the current status of trial NCT00982592?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2009-09. Estimated completion is 2014-10.

What conditions does trial NCT00982592 study?

This clinical trial studies the following conditions: Adenocarcinoma of the Gastroesophageal Junction, Stage IV Gastric Cancer, Recurrent Gastric Cancer, Stage IIIB Gastric Cancer, Adenocarcinoma of the Stomach.

What interventions are being tested in trial NCT00982592?

The interventions under investigation include: placebo (OTHER), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), vismodegib (DRUG).

Who is sponsoring clinical trial NCT00982592?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00982592 being conducted?

This trial has 20 study locations across California, Illinois, Indiana, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00982592, the US trial registry maintained by the National Library of Medicine. NCT00982592 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.