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

Phase 2
Completed
Conditions
Gastroesophageal Adenocarcinoma
Gastric Adenocarcinoma
Registration Number
NCT00073502
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
43
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

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

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

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University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States

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