Biliary Tract CancerPhase 3NCT00090025
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
A Phase 3 study testing becatecarin and 5-Fluorouracil Plus Leucovorin in people with Biliary Tract Cancer, run by Helsinn Healthcare SA at 59 sites in 11 countries.
Trial summary
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- becatecarin and 5-Fluorouracil Plus Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 59 sitesin 11 countries
- Study dates
- Sep 2004to Nov 2006
- Phase
- Phase 3
- 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
- Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
- 18 years or older
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
- Willing and able to sign informed consent
- Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide)
- Women of child-bearing age must have a negative pregnancy test
- Laboratory criteria
Who cannot join
- Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
- Unstable angina, or class III or IV New York Heart Association heart disease
- Central nervous system metastases
- Uncontrolled diabetes mellitus
- Uncontrolled seizure disorder
- Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
Show all 9Show fewer
- Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation
- Pregnant or breast-feeding
- A known history of human immunodeficiency virus (HIV) infection
Trial locations and contacts
59 sites in 11 countries.
59 sites in 11 countries
United States27 sites
Winship Cancer Institute, Emory University Hospital
Atlanta, Georgia, 30322
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
Cancer Treatment and Research Center
Bismarck, North Dakota, 58501
Tufts - New England Medical Center
Boston, Massachusetts, 02111
Gabrail Cancer Center
Canton, Ohio, 44718
Oncology Associates
Cedar Rapids, Iowa, 52403
Charleston Hematology Oncology, PA
Charleston, South Carolina, 29403
Case Western Reserve University
Cleveland, Ohio, 44106
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202
Queens Hospital Center
Jamaica, New York, 11432
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Western Washington Oncology, Inc.
Lacey, Washington, 98503
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Long Beach VA Medical Center
Long Beach, California, 90822
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Medical Consultants, PC c/o Ball Cancer Center
Muncie, Indiana, 47303
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Yale University School of Medicine
New Haven, Connecticut, 06520
University of California, Irvine Medical Center
Orange, California, 92868
Oncology Care Center PLLC
Saint Joseph, Michigan, 49085
Sharp Clinical Oncology Research
San Diego, California, 92123
Pacific Hematology Oncology Associates
San Francisco, California, 94115
SUNY Upstate Medical University
Syracuse, New York, 13210
Tampa General Hospital
Tampa, Florida, 33606
Carle Clinic Association
Urbana, Illinois, 61801
New York Medical College
Valhalla, New York, 10595
Germany9 sites
Charite Berlin der Humbold Universitat
Berlin, D-13353
Heinrich-Heine-Universitat-Dusseldorf
Düsseldorf, D-40225
Allgem. Krankenhaus St. Georg
Hamburg, D-20099
Medizinische Hochschule Hannover
Hanover, D-30625
Universitätsklinikum Johannes Gutenberg
Mainz, D-55131
Technischen Universitat Munchen
Munich, 81675
Klinikum Grosshadern der Ludwig Maximilians Universitaet
Munich
Universitätsklinikum Tübingen
Tübingen, D-72076
Universitatsklinikum Ulm
Ulm, D-89081
Spain6 sites
Hospital Clinic i Provincial (Oncology Department)
Barcelona, 08036
Hospital Clínico San Carlos
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital Regional Universitario Carlos Haya
Málaga
Hospital Provincial de Pontevedra
Pontevedra
Hospital Lozano Blesa
Zaragoza, 50009
Canada5 sites
London Regional Cancer Centre
London, Ontario, N6A 4L6
Centre Hospitalier Universite de Montreal
Montreal, Quebec
Jewish General Hospital
Montreal, Quebec
Ottawa Regional Cancer Centre
Ottawa, Ontario
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
France4 sites
CHU - Hospital Jean Minjoz
Besançon, 25030
Hospital Ambroise Pare
Boulogne-Billancourt, 92100
Centre Oscar Lambret
Lille, BP 307 - 59020
Institut Gustave Roussy
Villejuif, 94805
Italy3 sites
Centro di Riferimento Oncologico di Aviano
Aviano
Ospidale Civile di Livorno
Livorno, 57128
Policlinico Universitario di Udine
Udine, 33100
Russia1 site
Cancer Research Center named after N.N. Blokhin, RAMS
Moscow, 115478
About this study
Official title: A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
- Conditions
- Biliary Tract Cancer
- Being tested
- becatecarin, 5-Fluorouracil Plus Leucovorin
- Keywords
- Advanced Biliary Cancer, Cholangiocarcinoma, Gall bladder tumor, Gall bladder cancer, Bile duct tumor, Tumor of biliary tree
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
becatecarinDrug
Also called XL119
Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle
5-Fluorouracil Plus LeucovorinDrug
5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| becatecarin | Experimental | becatecarin Receives: Drug: becatecarin |
| 5-FU Plus Leucovorin (LV) | Active comparator | 5-Fluorouracil (5-FU) Plus Leucovorin (LV) Receives: Drug: 5-Fluorouracil Plus Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare survival duration for XL119 and 5-FU/LV treated subjects
Measured: time to death
Secondary outcomes (1)
To determine time to progressive disease for XL119 and 5-FU/LV treated subjects, to evaluate clinical benefit for XL119 and 5-FU/LV treated subjects, and to assess the safety profile of XL119
Measured: time to progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2004 (estimated)
- Study startSep 2004
- Primary completionNov 2006
- Study completionNov 2006
Why it stopped: Futility reasons after Independent Data Monitoring Committee interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Afshin Dowlati, MD, Study chair, Case Western Reserve University - Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090025
- Sponsor's protocol ID
- XL119-001
- Status last verified
- Jan 2009
- First submitted
- 19 Aug 2004
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery
- ClinicalTrials.gov ID
- NCT00090025
- Acronym / sponsor ID
- XL119-001
- Conditions
- Biliary Tract Cancer
- Keywords
- Advanced Biliary Cancer, Cholangiocarcinoma, Gall bladder tumor, Gall bladder cancer, Bile duct tumor, Tumor of biliary tree
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility reasons after Independent Data Monitoring Committee interim analysis
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 23 Aug 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.
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| becatecarin | Experimental | Drug: becatecarinbecatecarin |
| 5-FU Plus Leucovorin (LV) | Active comparator | Drug: 5-Fluorouracil Plus Leucovorin5-Fluorouracil (5-FU) Plus Leucovorin (LV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
- 18 years or older
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
- Willing and able to sign informed consent
Key exclusion criteria (9 listed)
- Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
- Unstable angina, or class III or IV New York Heart Association heart disease
- Central nervous system metastases
- Uncontrolled diabetes mellitus
- Uncontrolled seizure disorder
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 |
|---|---|---|
| becatecarinAlso: XL119Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle | Drug | becatecarin |
| 5-Fluorouracil Plus Leucovorin5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle | Drug | 5-FU Plus Leucovorin (LV) |
Primary outcome
To compare survival duration for XL119 and 5-FU/LV treated subjects
Time frame: time to death
1 secondary outcome
To determine time to progressive disease for XL119 and 5-FU/LV treated subjects, to evaluate clinical benefit for XL119 and 5-FU/LV treated subjects, and to assess the safety profile of XL119
Time frame: time to progressive disease
Results and safety
The study was stopped early (reason given: Futility reasons after Independent Data Monitoring Committee interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
Related trials for Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
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.
Afshin Dowlati, MD study chair
Case Western Reserve University - Cleveland
59 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing becatecarin and 5-Fluorouracil Plus Leucovorin in people with Biliary Tract Cancer, run by Helsinn Healthcare SA at 59 sites in 11 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Germany, Spain, Canada, France and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Futility reasons after Independent Data Monitoring Committee interim analysis). Results are not available in the source record.
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.
What does the primary outcome measure?
To compare survival duration for XL119 and 5-FU/LV treated subjects (time frame: time to death). It is what the study was designed to measure, not a finding.
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 14 Jan 2009.