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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00073502
Recruitment Status : Completed
First Posted : November 25, 2003
Last Update Posted : February 22, 2006
Sponsor:
Information provided by:
OSI Pharmaceuticals

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
Gastroesophageal Adenocarcinoma Gastric Adenocarcinoma Drug: OSI-7904L Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 43 participants
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 : October 2003
Study Completion Date : October 2003




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073502


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

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ClinicalTrials.gov Identifier: NCT00073502     History of Changes
Other Study ID Numbers: OSI-904-201
First Posted: November 25, 2003    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: October 2003

Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms