NCT00088270

Brief Summary

Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2

Geographic Reach
6 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

February 22, 2006

Status Verified

May 1, 2004

First QC Date

July 23, 2004

Last Update Submit

February 17, 2006

Conditions

Locally Advanced or Metastatic Adenoca of the Biliary Tract

Interventions

OSI-7904LDRUG
5-Fluorouracil/LeucovorinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented locally advanced or metastatic adenocarcinoma of the biliary tract; Adequate bone marrow, hepatic and renal function; Bilirubin \<= 1.5 times the upper limit of normal; Age 18 years or older; Predicted life expectancy 12 weeks or more; Prior surgery and radiation therapy permitted provided patient has recovered adequately; At least 1 target lesion \>= 20 mm (or \>= 10 mm on spiral CT-scan); ECOG Performance Status 0-2; No prior chemotherapy for locally advanced or metastatic disease. Adjuvant/neo-adjuvant permitted if therapy was completed at least 12 months prior to study entry;

You may not qualify if:

  • Concurrent anticancer therapy while on study; History of other malignancy within the past 3 years except basal or squamous cell carcinoma or in situ cervical cancer; Symptomatic brain metastases which are not stable or have required radiation in the past 28 days;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Robert H. Lurie Comp. Cancer Ctr of Northwestern University

Chicago, Illinois, 60611, United States

Location

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Division of Hematology/Oncology

Columbus, Ohio, 43210, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232, United States

Location

Institute Jules Bordet

1000 Brussels, Belgium

Location

Dept Internal Medicine Gastrointestinal Oncology Unit

B-3000 Leuven, Belgium

Location

Department of Gastroenterology and GI Oncology

Brussels, Belgium

Location

Universitätsklinikum Charite Campus Virchow

13353 Berlin, Germany

Location

Allgemeines Krankenhaus St. Georg

20099 Hamburg, Germany

Location

Klinikum der J. W. Groethe-Universitat

60590 Frankfurt, Germany

Location

Innere Medizin Universitatsklinikum Heidelberg

69115 Heidelberg, Germany

Location

Medizinische Klinik II LMU-Klinikum-Großhadern

81377 München, Germany

Location

Tumorforschung Innere Medizinische Klinik

Essen, 45122, Germany

Location

Klinika Nowotworow Gornego Odcinka

02-791 Warszawa, Poland

Location

Klinika Chemioterapii

31-115 Krakow, Poland

Location

Institutul Clinic Fundeni

72437 Bucuresti, Romania

Location

Oncology Institute Ion Chiricuta

Cluj-Napoca, 3400, Romania

Location

Oncosurgery University Hospital of Geneva

1211 Geneva 14, Switzerland

Location

Multidisciplinary Oncology Center University Hospital CHUV

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

((S)-2-(5-(1,2-dihydro-3-methyl-1-oxobenzo(f)-quinazoline-9-yl)methyl)amino-1-oxo-2-isoindolynyl)-glutaric acidFluorouracilLeucovorin

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 23, 2004

First Posted

July 26, 2004

Study Start

August 1, 2004

Study Completion

August 1, 2005

Last Updated

February 22, 2006

Record last verified: 2004-05

Locations

US(6)CH(2)PL(2)DE(6)BE(3)RO(2)