CholangiocarcinomaPhase 2GOC-B-PNCT01206049
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
A Phase 2 study testing Gemcitabine, Oxaliplatin and Capecitabine in people with Cholangiocarcinoma, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Gemcitabine, Oxaliplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Mar 2016
- 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 verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma
- Minimum 18 years of age
- Curative treatment currently not an option (operation, stereotactic radiation treatment or similar)
- KRAS analyzed and found wild-type (wt)
- Performance status 0-2
- Evaluable disease according to RECIST, i.e. the disease need not be measurable
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- Hematology: ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l
- Biochemistry: Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal level.
- Creatinine ≤ upper normal level. At raised creatinine level the measured or calculated GFR must be at least 50% of the lower normal level
- Fertile women must present a negative pregnancy test and use secure birth control during and 6 months after treatment. Men with fertile partners must also take care of secure birth control.
- Written and orally informed consent
Who cannot join
- Previous cytostatic treatment of inoperable cholangiocarcinoma
- Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
- Other concomitant experimental treatment
- Severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator
- Other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri
- Interstitial pneumonitis or subsequent pulmonary fibrosis
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- Pregnant or breastfeeding women
- Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
- Significant non-healing wound or ulcers
- Active hemorrhage or increased risk of hemorrhage (e.g. tumor invasion in large vessels or known esophagus varices)
- Known hypersensitivity to panitumumab, bevacizumab or any of the auxiliary agents
- Grade IV fistulas
- Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilized hypertension >160/100
- Haemoptysis > 2.5 ml within 2 weeks prior to enrolment
- Previous serious and unexpected reactions or know hypersensitivity to two or more of the applied cytostatics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations
The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.
- Conditions
- Cholangiocarcinoma
- Being tested
- Gemcitabine, Oxaliplatin, Capecitabine, Panitumumab, Bevacizumab
- Keywords
- Cholangiocarcinoma, Inoperable, KRAS mutation, Biological treatment, Combination chemotherapy, Monoclonal antibody
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
1,000 mg/m2 on day 1 of a 2 weeks cycle
OxaliplatinDrug
60 mg/m2 on day 1 of a 2 weeks cycle
CapecitabineDrug
1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
PanitumumabDrug
6 mg/kg on day 1 of a 2 weeks cycle
BevacizumabDrug
10 mg/kg on day 1 of a 2 weeks cycle
| Study group | Role | What they receive |
|---|---|---|
| Combination chemotherapy + panitumumab | Experimental | Not described Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Panitumumab |
| Combination chemotherapy + bevacizumab | Experimental | Not described Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fraction of patients alive and without progression at 6 months
Measured: 6 months from enrollment date
Secondary outcomes (3)
Response rate before cross-over
Measured: 6 months after enrollment or earlier in case of progression
Overall survival
Measured: 6 months
Progression free survival and response rate after cross-over
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, MD, DMSc, Study chair, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206049
- Sponsor's protocol ID
- 2010-020385-13
- Acronym
- GOC-B-P
- Status last verified
- Jun 2016
- First submitted
- 20 Sep 2010
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations
- ClinicalTrials.gov ID
- NCT01206049
- Acronym / sponsor ID
- GOC-B-P / 2010-020385-13
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, Inoperable, KRAS mutation, Biological treatment, Combination chemotherapy, Monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Sep 2010 (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 purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination chemotherapy + panitumumab | Experimental | Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Panitumumab |
| Combination chemotherapy + bevacizumab | Experimental | Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma
- Minimum 18 years of age
- Curative treatment currently not an option (operation, stereotactic radiation treatment or similar)
- KRAS analyzed and found wild-type (wt)
- Performance status 0-2
Key exclusion criteria (15 listed)
- Previous cytostatic treatment of inoperable cholangiocarcinoma
- Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
- Other concomitant experimental treatment
- Severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator
- Other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri
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 |
|---|---|---|
| Gemcitabine1,000 mg/m2 on day 1 of a 2 weeks cycle | Drug | Combination chemotherapy + bevacizumab, Combination chemotherapy + panitumumab |
| Oxaliplatin60 mg/m2 on day 1 of a 2 weeks cycle | Drug | Combination chemotherapy + bevacizumab, Combination chemotherapy + panitumumab |
| Capecitabine1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle | Drug | Combination chemotherapy + bevacizumab, Combination chemotherapy + panitumumab |
| Panitumumab6 mg/kg on day 1 of a 2 weeks cycle | Drug | Combination chemotherapy + panitumumab |
| Bevacizumab10 mg/kg on day 1 of a 2 weeks cycle | Drug | Combination chemotherapy + bevacizumab |
Primary outcome
The fraction of patients alive and without progression at 6 months
Time frame: 6 months from enrollment date
3 secondary outcomes
Response rate before cross-over
Time frame: 6 months after enrollment or earlier in case of progression
Overall survival
Time frame: 6 months
Progression free survival and response rate after cross-over
Time frame: 6 months
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 13 Mar 2017.
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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.
Anders Jakobsen, MD, DMSc study chair
Department of Oncology, Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Oxaliplatin and Capecitabine in people with Cholangiocarcinoma, run by Vejle Hospital at 1 site in Denmark.
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 11 inclusion and 15 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The fraction of patients alive and without progression at 6 months (time frame: 6 months from enrollment date). 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 13 Mar 2017.