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

Sponsor
OSI Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00073502
Collaborator
(none)
43
Enrollment
11
Locations
3.9
Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction
Study Start Date :
Oct 1, 2003
Study Completion Date :
Oct 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • OSI Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00073502
    Other Study ID Numbers:
    • OSI-904-201
    First Posted:
    Nov 25, 2003
    Last Update Posted:
    Feb 22, 2006
    Last Verified:
    Oct 1, 2003
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Feb 22, 2006