Locally Advanced or Metastatic Adenoca of the Biliary TractPhase 2NCT00088270
A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer
A Phase 2 study testing OSI-7904L and 5-Fluorouracil/Leucovorin in people with Locally Advanced or Metastatic Adenoca of the Biliary Tract, run by OSI Pharmaceuticals at 21 sites in 6 countries.
Trial summary
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Adenoca of the Biliary Tract
- What is being tested?
- OSI-7904L and 5-Fluorouracil/Leucovorin
- How many people
- 58 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Aug 2004to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Robert H. Lurie Comp. Cancer Ctr of Northwestern University
Chicago, Illinois, 60611
Division of Hematology/Oncology
Columbus, Ohio, 43210
Wayne State University
Detroit, Michigan, 48201
Vanderbilt Cancer Center
Nashville, Tennessee, 37232
Germany6 sites
Universitätsklinikum Charite Campus Virchow
13353 Berlin
Allgemeines Krankenhaus St. Georg
20099 Hamburg
Klinikum der J. W. Groethe-Universitat
60590 Frankfurt
Innere Medizin Universitatsklinikum Heidelberg
69115 Heidelberg
Medizinische Klinik II LMU-Klinikum-Großhadern
81377 München
Tumorforschung Innere Medizinische Klinik
Essen, 45122
Belgium3 sites
Institute Jules Bordet
1000 Brussels
Dept Internal Medicine Gastrointestinal Oncology Unit
B-3000 Leuven
Department of Gastroenterology and GI Oncology
Brussels
Poland2 sites
Klinika Nowotworow Gornego Odcinka
02-791 Warszawa
Klinika Chemioterapii
31-115 Krakow
Romania2 sites
Institutul Clinic Fundeni
72437 Bucuresti
Oncology Institute Ion Chiricuta
Cluj-Napoca, 3400
Switzerland2 sites
Oncosurgery University Hospital of Geneva
1211 Geneva 14
Multidisciplinary Oncology Center University Hospital CHUV
Lausanne, 1011
About this study
Official title: A Randomized, Open Label, Phase II Study of OSI-7904L Versus 5-FU/LV as First-Line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Adenocarcinoma of the Biliary Tract
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.
- Being tested
- OSI-7904L, 5-Fluorouracil/Leucovorin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-7904LDrug
5-Fluorouracil/LeucovorinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study startAug 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Adenoca of the Biliary TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088270
- Sponsor's protocol ID
- OSI-904-202
- Status last verified
- May 2004
- First submitted
- 23 Jul 2004
- Last updated
- 22 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Phase II Study of OSI-7904L Versus 5-FU/LV as First-Line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Adenocarcinoma of the Biliary Tract
- ClinicalTrials.gov ID
- NCT00088270
- Acronym / sponsor ID
- OSI-904-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Aug 2005
- First posted
- 26 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSI-7904L | Drug | – |
| 5-Fluorouracil/Leucovorin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSI-7904L and 5-Fluorouracil/Leucovorin in people with Locally Advanced or Metastatic Adenoca of the Biliary Tract, run by OSI Pharmaceuticals at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Belgium, Poland, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2006.