Biliary Tract CancerPhase 2NCT00142480
Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer
A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Biliary Tract Cancer and Gallbladder Adenocarcinoma, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The main purpose of this study is to test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer, Gallbladder Adenocarcinoma
- What is being tested?
- Capecitabine, Oxaliplatin and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2004to Apr 2011
- 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
- Histologically confirmed locally advanced unresectable biliary tract or gallbladder adenocarcinoma
- Patients with resected biliary tract or gallbladder adenocarcinoma who have residual tumor left will also be eligible.
- > 4 weeks since time of major surgery
- > 2 weeks since time of minor surgery
- > 4 weeks since time of major radiotherapy for other malignancy
- > 4 weeks since participation in any investigational drug study
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- > 1 year since treatment for other carcinomas, except cured non-melanoma skin and treated in-situ cervical cancer
- 18 years of age or older
- ECOG performance status of 0-2
- Life expectancy > 12 weeks
- Absolute neutrophil count (ANC) > 1,500/mm3
- Hemoglobin > 9.0 gm/dl
- Platelets > 100,000/mm3
- SGOT < 5 x upper limits of normal (ULN)
- Total bilirubin < 2.5 mg/dl
- Creatinine clearance > 50 ml/min
Who cannot join
- Prior chemotherapy or radiation therapy for biliary tract or gallbladder cancer
- Peripheral neuropathy of grade 2 or greater
- Unstable angina
- Symptomatic congestive heart failure
- Myocardial infarction < 12 months prior to registration
- New York Heart Association classification III or IV
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- Active or uncontrolled infection
- Known existing uncontrolled coagulopathy
- Malabsorption syndrome or lack of integrity of the upper gastrointestinal (GI) tract
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency
- Known brain metastases or carcinomatous meningitis
- Pregnant or lactating women
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer
The main purpose of this study is to test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer.
Read the detailed description
There are two phases of study treatment. The first phase is for all patients and will last about 6 weeks. During this phase, oxaliplatin will be given intravenously once a week during weeks 1, 2, 4, and 5 on days 1, 8, 22, and 29; bevacizumab will be given intravenously once every 2 weeks during weeks 1, 3, and 5 on days 1, 15, and 29; capecitabine will be administered orally for 14 consecutive days (days 1-14), then a week of no capecitabine, followed by another 14 days of capecitabine (days 22-35).
Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments.
During this first phase of the study the following tests will be performed weekly: physical exam, vital signs, medical history, blood tests and urine tests.
After the first phase is finished patients will wait 4 weeks then have a CT scan, MRCP, blood tests and a physical exam to evaluate the status of the disease.
Phase two of the study is broken up into two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease.
If the patients had tumors removed prior to entering the study, they will be treated again with all 3 study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of treatment.
Patients with advanced disease that could not be removed by surgery when they first entered the study but the evaluation tests after the first phase show the tumor has responded (reduced in size) and can now be resected, will have surgery to remove the tumors.
Following surgical recovery (8-10 weeks) they will be treated again with all 3 of the study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.
If the evaluation tests show that the patients' cancer has remained stable (not gotten worse or better) they will be treated again with all three study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.
During the additional 12 weeks of study treatment a physical exam, vital signs, medical history, blood testing and urine testing will be performed once every 3 weeks.
At the end of study treatment the following evaluations will be performed: physical exam, vital signs, blood work, CT scan of the chest and abdomen, MRCP, and tumor measurements by CT scans. These evaluations will be repeated every 3 months thereafter.
Patients will be removed from the study if their disease worsens or there are unacceptable side effects.
- Conditions
- Biliary Tract Cancer, Gallbladder Adenocarcinoma
- Being tested
- Capecitabine, Oxaliplatin, Bevacizumab, Radiation therapy
- Keywords
- locally advanced biliary adenocarcinoma, unresectable biliary adenocarcinoma, gallbladder adenocarcinoma, capecitabine, oxaliplatin, bevacizumab, Biliary tract adenocarcinoma
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Given orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28).
OxaliplatinDrug
Given intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29
BevacizumabDrug
Given intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29.
Radiation therapyProcedure or surgery
Once daily for 5 days (Monday through Friday) for a total of 28 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine, Oxaliplatin, Bevacizumab | Experimental | There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment. Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab; Procedure: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients
Measured: 3 years
Secondary outcomes (1)
To evaluate the safety of the combination capecitabine, oxaliplatin, bevacizumab in patients with biliary tract and gallbladder cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2007
- Study completionApr 2011
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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Sanofi-Synthelabo, Hoffmann-La Roche
- Responsible party
- Principal investigator, Andrew X. Zhu, MD, Massachusetts General Hospital
- Investigators
- Andrew Zhu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142480
- Sponsor's protocol ID
- 04-144
- Status last verified
- Apr 2018
- First submitted
- 31 Aug 2005
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT00142480
- Acronym / sponsor ID
- 04-144
- Conditions
- Biliary Tract Cancer, Gallbladder Adenocarcinoma
- Keywords
- locally advanced biliary adenocarcinoma, unresectable biliary adenocarcinoma, gallbladder adenocarcinoma, capecitabine, oxaliplatin, bevacizumab, Biliary tract adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Sanofi-Synthelabo, Hoffmann-La Roche
- Study start
- Dec 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Sep 2005 (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 test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer.
Detailed description
There are two phases of study treatment. The first phase is for all patients and will last about 6 weeks. During this phase, oxaliplatin will be given intravenously once a week during weeks 1, 2, 4, and 5 on days 1, 8, 22, and 29; bevacizumab will be given intravenously once every 2 weeks during weeks 1, 3, and 5 on days 1, 15, and 29; capecitabine will be administered orally for 14 consecutive days (days 1-14), then a week of no capecitabine, followed by another 14 days of capecitabine (days 22-35).
Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments.
During this first phase of the study the following tests will be performed weekly: physical exam, vital signs, medical history, blood tests and urine tests.
After the first phase is finished patients will wait 4 weeks then have a CT scan, MRCP, blood tests and a physical exam to evaluate the status of the disease.
Phase two of the study is broken up into two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease.
If the patients had tumors removed prior to entering the study, they will be treated again with all 3 study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of treatment.
Patients with advanced disease that could not be removed by surgery when they first entered the study but the evaluation tests after the first phase show the tumor has responded (reduced in size) and can now be resected, will have surgery to remove the tumors.
Following surgical recovery (8-10 weeks) they will be treated again with all 3 of the study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.
If the evaluation tests show that the patients' cancer has remained stable (not gotten worse or better) they will be treated again with all three study drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week regimen will be repeated twice for a total of 12 weeks of study treatment.
During the additional 12 weeks of study treatment a physical exam, vital signs, medical history, blood testing and urine testing will be performed once every 3 weeks.
At the end of study treatment the following evaluations will be performed: physical exam, vital signs, blood work, CT scan of the chest and abdomen, MRCP, and tumor measurements by CT scans. These evaluations will be repeated every 3 months thereafter.
Patients will be removed from the study if their disease worsens or there are unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine, Oxaliplatin, Bevacizumab | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Drug: Bevacizumab, Procedure: Radiation therapyThere are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed locally advanced unresectable biliary tract or gallbladder adenocarcinoma
- Patients with resected biliary tract or gallbladder adenocarcinoma who have residual tumor left will also be eligible.
- > 4 weeks since time of major surgery
- > 2 weeks since time of minor surgery
- > 4 weeks since time of major radiotherapy for other malignancy
Key exclusion criteria (14 listed)
- Prior chemotherapy or radiation therapy for biliary tract or gallbladder cancer
- Peripheral neuropathy of grade 2 or greater
- Unstable angina
- Symptomatic congestive heart failure
- Myocardial infarction < 12 months prior to registration
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 |
|---|---|---|
| CapecitabineGiven orally for 14 consecutive days (days 1-14) followed by a week of no capecitabine then another week of 14 consecutive days (days 21-28). | Drug | Capecitabine, Oxaliplatin, Bevacizumab |
| OxaliplatinGiven intravenously once weekly during weeks 1, 2, 4 and 5 on days 1, 8, 22 and 29 | Drug | Capecitabine, Oxaliplatin, Bevacizumab |
| BevacizumabGiven intravenously every two weeks during weeks 1, 3 and 5 on days 1, 15 and 29. | Drug | Capecitabine, Oxaliplatin, Bevacizumab |
| Radiation therapyOnce daily for 5 days (Monday through Friday) for a total of 28 treatments. | Procedure or surgery | Capecitabine, Oxaliplatin, Bevacizumab |
Primary outcome
To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients
Time frame: 3 years
1 secondary outcome
To evaluate the safety of the combination capecitabine, oxaliplatin, bevacizumab in patients with biliary tract and gallbladder cancer
Time frame: 3 years
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 25 Apr 2018.
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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.
Andrew Zhu, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Oxaliplatin and Bevacizumab in people with Biliary Tract Cancer and Gallbladder Adenocarcinoma, run by Massachusetts General Hospital at 3 sites in United States.
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 16 inclusion and 14 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 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does the primary outcome measure?
To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients (time frame: 3 years). 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 25 Apr 2018.