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

Primary Purpose

Gastroesophageal Adenocarcinoma, Gastric Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OSI-7904L
Sponsored by
OSI Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania Cancer Center
  • MD Anderson Cancer Center
  • University of Utah, Huntsman Cancer Institute
  • Dept Internal Medicine Gastrointestinal Oncology Unit
  • Bristol Haematology & Oncology Centre
  • ICRF Medical Oncology Unit
  • Deanesly Centre
  • NICCTU, East Podium, C-Floor
  • Beatson Oncology Centre
  • Cookridge Hospital
  • Department of Medical Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 21, 2003
Last Updated
February 17, 2006
Sponsor
OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00073502
Brief Title
Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
OSI Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Adenocarcinoma, Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
43 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OSI-7904L

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Dept Internal Medicine Gastrointestinal Oncology Unit
City
B-3000 Leuven
Country
Belgium
Facility Name
Bristol Haematology & Oncology Centre
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
ICRF Medical Oncology Unit
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Deanesly Centre
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
NICCTU, East Podium, C-Floor
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Beatson Oncology Centre
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
ZIP/Postal Code
LS16 6BB
Country
United Kingdom
Facility Name
Department of Medical Oncology
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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