CholangiocarcinomaPhase 2NCT01247337
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
A Phase 2 study testing Oxaliplatin, capecitabine, gemcitabine, cetuximab and Oxaliplatin, capecitabine, gemcitabine cetuximab in people with Cholangiocarcinoma, run by Dorte Nielsen at 1 site in Denmark.
Trial summary
A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Oxaliplatin, capecitabine, gemcitabine, cetuximab and Oxaliplatin, capecitabine, gemcitabine cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Feb 2011to 18 Feb 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
- Age > 18 years
- Performance status 0-1; expected survival ≥ 3 months
- Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma
- Liver metastases not suitable for surgery or other local treatment
- Extrahepatic disease should be excluded by PET-CT-scan.
- Prior treatment with chemotherapy or no progression on first line treatment
Show all 27Show fewer
- Metastases < 70 % of the liver
- neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l
- bilirubin < 2.0 x UNL (upper normal limit).
- creatinine-clearance ≥ 30 ml/min.
- INR < 2.
- Intrahepatic treatment can be accomplished
- The patients is approved by a multidisciplinary team
- Exclusion Criteria:• Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
- Cytotoxic or experimental treatment within a 14 days period before start of trial medication
- The patient is not allowed to participate in other clinical trials.
- Any clinical symptoms suggesting peripheral neuropathy grade 2
- Other severe medical conditions
- Severe cardial disease or AMI < 1 year
- Presence of diseases preventing oral therapy
- Patients with uncontrolled infection
- Pregnant or lactating women
- Women capable of childbearing not using a sufficient method of birth control
- Patients not able to understand the treatment or to collaborate
- Prior serious or unsuspected reaction after treatment with fluoropyrimidine
- Known prior hypersensitivity reactions to the agents
- Interstitial pneumonitis or pulmonary fibrosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.
A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma
- Being tested
- Oxaliplatin, capecitabine, gemcitabine, cetuximab, Oxaliplatin, capecitabine, gemcitabine cetuximab
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin, capecitabine, gemcitabine, cetuximabDrug
Intrahepatic oxaliplatin
Oxaliplatin, capecitabine, gemcitabine cetuximabDrug
Oxaliplatin given intravenous
| Study group | Role | What they receive |
|---|---|---|
| Single arm chemotherapy treatment | Experimental | Not described Receives: Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab; Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Time from treatment start to progression or death.
Measured: 6 months after last patient included
Secondary outcomes (3)
Response rate.
Measured: 6 months after last patient included
Survival
Measured: 6 months after last patient included
Toxicity
Measured: 28 days after last treatment of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study start2 Feb 2011
- Primary completion18 Feb 2016
- Study completion18 Feb 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dorte Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dorte Nielsen, Herlev Hospital
- Investigators
- Magnus Bergenfeldt, Consultan, Principal investigator, Department og Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247337
- Sponsor's protocol ID
- GI 1003
- Status last verified
- Oct 2020
- First submitted
- 23 Nov 2010
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.
- ClinicalTrials.gov ID
- NCT01247337
- Acronym / sponsor ID
- GI 1003
- Conditions
- Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dorte NielsenUniversity, hospital or other
- Study start
- 2 Feb 2011 (actual)
- Primary completion
- 18 Feb 2016 (actual)
- Study completion
- 18 Feb 2016 (actual)
- First posted
- 24 Nov 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.
A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm chemotherapy treatment | Experimental | Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab, Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Age > 18 years
- Performance status 0-1; expected survival ≥ 3 months
- Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma
- Liver metastases not suitable for surgery or other local treatment
- Extrahepatic disease should be excluded by PET-CT-scan.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oxaliplatin, capecitabine, gemcitabine, cetuximabIntrahepatic oxaliplatin | Drug | Single arm chemotherapy treatment |
| Oxaliplatin, capecitabine, gemcitabine cetuximabOxaliplatin given intravenous | Drug | Single arm chemotherapy treatment |
Primary outcome
PFS
Time frame: 6 months after last patient included
Time from treatment start to progression or death.
3 secondary outcomes
Response rate.
Time frame: 6 months after last patient included
Survival
Time frame: 6 months after last patient included
Toxicity
Time frame: 28 days after last treatment of last patient
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 5 Oct 2020.
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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.
Magnus Bergenfeldt, Consultan principal investigator
Department og Gastroenterology
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 Oxaliplatin, capecitabine, gemcitabine, cetuximab and Oxaliplatin, capecitabine, gemcitabine cetuximab in people with Cholangiocarcinoma, run by Dorte Nielsen 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 27 inclusion and 0 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 5 Oct 2020. 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?
PFS (time frame: 6 months after last patient included). 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 5 Oct 2020.