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

This study has been completed.

First Received: November 21, 2003 Last Updated: February 17, 2006 History of Changes

Sponsor:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00073502

Purpose

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	Intervention	Phase
Gastroesophageal Adenocarcinoma Gastric Adenocarcinoma	Drug: OSI-7904L	Phase II

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:	43
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073502

Locations

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
NICCTU, East Podium, C-Floor
Belfast, United Kingdom, BT9 7AB
Beatson Oncology Centre
Glasgow, United Kingdom, G11 6NT
Department of Medical Oncology
Manchester, United Kingdom, M20 4BX
Cookridge Hospital
Leeds, United Kingdom, LS16 6BB
United Kingdom, Avon
Bristol Haematology & Oncology Centre
Bristol, Avon, United Kingdom, BS2 8ED
United Kingdom, Oxfordshire
ICRF Medical Oncology Unit
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
United Kingdom, West Midlands
Deanesly Centre
Wolverhampton, West Midlands, United Kingdom, WV10 0QP

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	OSI-904-201
Study First Received:	November 21, 2003
Last Updated:	February 17, 2006
ClinicalTrials.gov Identifier:	NCT00073502 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasms by Histologic Type

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 09, 2009