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COMPLETED Phase 2

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

NCT00982592 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00982592

The ClinicalTrials.gov registry entry for NCT00982592 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00982592 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Illinois, New York, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00982592?

The interventions under investigation include: placebo (OTHER), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), vismodegib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00982592?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial