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

Completed · Phase 2

Conditions studied: Gastroesophageal Adenocarcinoma, Gastric Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00073502

Run by

OSI Pharmaceuticals

People needed

43

Starts

2003-10-01

Expected to finish

2003-10-01

Last updated by the study team

2006-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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