Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer

February 17, 2006 updated by: OSI Pharmaceuticals

A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction

Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

43

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

  • Belgium
      • B-3000 Leuven, Belgium
        • Dept Internal Medicine Gastrointestinal Oncology Unit
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • NICCTU, East Podium, C-Floor
      • Glasgow, United Kingdom, G11 6NT
        • Beatson Oncology Centre
      • Leeds, United Kingdom, LS16 6BB
        • Cookridge Hospital
      • Manchester, United Kingdom, M20 4BX
        • Department of Medical Oncology
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8ED
        • Bristol Haematology & Oncology Centre
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • ICRF Medical Oncology Unit
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • Deanesly Centre
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah, Huntsman Cancer Institute

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:

Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age >= 18 years At least one target lesion

Exclusion Criteria:

Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable

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

Collaborators and Investigators

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

Sponsor

OSI Pharmaceuticals

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

October 1, 2003

Study Completion

October 1, 2003

Study Registration Dates

First Submitted

November 21, 2003

First Submitted That Met QC Criteria

November 24, 2003

First Posted (Estimate)

November 25, 2003

Study Record Updates

Last Update Posted (Estimate)

February 22, 2006

Last Update Submitted That Met QC Criteria

February 17, 2006

Last Verified

October 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-904-201

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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