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

Tracking Information
First Received Date ^ICMJE	November 21, 2003
Last Updated Date	February 17, 2006
Start Date ^ICMJE	October 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer
Official Title ^ICMJE	A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Gastroesophageal Adenocarcinoma Gastric Adenocarcinoma
Intervention ^ICMJE	Drug: OSI-7904L
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	43
Completion Date	October 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00073502
Responsible Party
Study ID Numbers ^ICMJE	OSI-904-201
Study Sponsor ^ICMJE	OSI Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	OSI Pharmaceuticals
Verification Date	October 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP