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NCT00073502 Clinical Trial

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

Gastric Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00073502
Other study ID # OSI-904-201
Secondary ID
Status Completed
Phase Phase 2
First received November 21, 2003
Last updated February 17, 2006
Start date October 2003
Est. completion date October 2003

Study information
Verified date October 2003
Source OSI Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• OSI-7904L

Locations
Country Name City State
Belgium Dept Internal Medicine Gastrointestinal Oncology Unit B-3000 Leuven
United Kingdom NICCTU, East Podium, C-Floor Belfast
United Kingdom Bristol Haematology & Oncology Centre Bristol Avon
United Kingdom Beatson Oncology Centre Glasgow
United Kingdom Cookridge Hospital Leeds
United Kingdom Department of Medical Oncology Manchester
United Kingdom ICRF Medical Oncology Unit Oxford Oxfordshire
United Kingdom Deanesly Centre Wolverhampton West Midlands
United States MD Anderson Cancer Center Houston Texas
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States University of Utah, Huntsman Cancer Institute Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  United Kingdom, 

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