CholangiocarcinomaPhase 1/2NCT00350961
Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
A Phase 1/2 study testing Gemcitabine, Oxaliplatin and Capecitabine in people with Cholangiocarcinoma, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No standard treatment exists for patients with advanced cholangiocarcinoma, and improved systemic treatments are needed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Gemcitabine, Oxaliplatin and Capecitabine
- How many people
- 39 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2004to Feb 2008
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven intra- or extrahepatic cholangiocarcinoma, papilla of the Vater or gallbladder carcinoma.
- PS 0-2
- Age 18-75
- Life expectancy > 12 weeks
- Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
- Bilirubin < 1,5 x UNL
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- Transaminases < 3 x UNL
- Normal renal function, Cr-EDTA clearance > 50 ml/min
- No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
- No known DPD-deficiency
- No neuropathy
- No uncontrolled, severe concurrent medical disease
- Signed informed consent
Who cannot join
- Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
- Experimental therapy < 8 weeks prior to inclusion
- Uncontrolled, severe concurrent medical disease
- Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
- Allergy to gemcitabine, oxaliplatin or capecitabine
- Pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No standard treatment exists for patients with advanced cholangiocarcinoma, and improved systemic treatments are needed.
Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers and several different regimens are well tolerated and active, especially in upper gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer.
Read more
The triplet combination of these agents has not been studied, but a triplet combination of gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study.
Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during therapy seems to be saturable.
We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and capecitabine. This regimen could be feasible in an out-patients setting.
The phase I part is a standard dose escalation study for patients with solid tumors. In the phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.
Read the detailed description
Design
Open, non-randomized phase I/II study.
Purpose:
Phase I part To find MTD and RFTD for the combination of gemcitabine, oxaliplatin and capecitabine.
Dose Escalating Schedule Dose level Dose Gemcitabine 10 mg/m2/min 600-1000 mg/m2 day 1 and 14 Capecitabine p.o. x 2 daily. 1000-1250 mg/m2 day 1-7 and 14-21 Oxaliplatin 60-80 mg/m2day 1 and 14 Drugs: G C O Level 1 600 1000 60 Level 2 800 1000 60 Level 3 1000 1000 60 Level 4 1000 1250 60 Level 5 1000 1250 80 Level 6 1200 1250 80 Start level: Level 1, 3 patients per level
Phase II part The primary endpoint is the objective response rate The secondary endpoint is toxicity, response duration and time to progression.
Treatment:
Gemcitabine Gemcitabine is given intravenously on day 1 and 14 with a fixed dose rate of 10 mg/m2/min.
Oxaliplatin Oxaliplatin is given intravenously on day 1 and 14 as a 2 hours infusion.
Capecitabine Capecitabine is given orally and administered in tablets of 150 mg and 500 mg. The dose is administered twice daily with 12 hours interval, in the morning and evening during or latest 30 minutes after a meal.
- Conditions
- Cholangiocarcinoma
- Being tested
- Gemcitabine, Oxaliplatin, Capecitabine
- Keywords
- Cholangiocarcinoma, Fixed dose rate, Gemcitabine, Oxaliplatin, Capecitabine
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
OxaliplatinDrug
CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Secondary outcomes (3)
Safety
Time to progression
SUrvival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startJun 2004
- Study completionFeb 2008
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Henrik Jensen, Dept. of Oncology, Vejle Sygehus, Vejle, Denmark
- Investigators
- Ulrik Lassen, MD., PH.D., Principal investigator, Rigshospitalet, Dept. of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350961
- Sponsor's protocol ID
- GEMOXEL cholangiocarcinoma
- Status last verified
- Aug 2008
- First submitted
- 10 Jul 2006
- Last updated
- 26 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT00350961
- Acronym / sponsor ID
- GEMOXEL cholangiocarcinoma
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, Fixed dose rate, Gemcitabine, Oxaliplatin, Capecitabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Henrik Jensen, Dept. of Oncology, Vejle Sygehus, Vejle, Denmark
- Study start
- Jun 2004
- Study completion
- Feb 2008 (actual)
- First posted
- 11 Jul 2006 (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.
In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No standard treatment exists for patients with advanced cholangiocarcinoma, and improved systemic treatments are needed.
Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers and several different regimens are well tolerated and active, especially in upper gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer.
The triplet combination of these agents has not been studied, but a triplet combination of gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study.
Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during therapy seems to be saturable.
We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and capecitabine. This regimen could be feasible in an out-patients setting.
The phase I part is a standard dose escalation study for patients with solid tumors. In the phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.
Detailed description
Design
Open, non-randomized phase I/II study.
Purpose:
Phase I part To find MTD and RFTD for the combination of gemcitabine, oxaliplatin and capecitabine.
Dose Escalating Schedule Dose level Dose Gemcitabine 10 mg/m2/min 600-1000 mg/m2 day 1 and 14 Capecitabine p.o. x 2 daily. 1000-1250 mg/m2 day 1-7 and 14-21 Oxaliplatin 60-80 mg/m2day 1 and 14 Drugs: G C O Level 1 600 1000 60 Level 2 800 1000 60 Level 3 1000 1000 60 Level 4 1000 1250 60 Level 5 1000 1250 80 Level 6 1200 1250 80 Start level: Level 1, 3 patients per level
Phase II part The primary endpoint is the objective response rate The secondary endpoint is toxicity, response duration and time to progression.
Treatment:
Gemcitabine Gemcitabine is given intravenously on day 1 and 14 with a fixed dose rate of 10 mg/m2/min.
Oxaliplatin Oxaliplatin is given intravenously on day 1 and 14 as a 2 hours infusion.
Capecitabine Capecitabine is given orally and administered in tablets of 150 mg and 500 mg. The dose is administered twice daily with 12 hours interval, in the morning and evening during or latest 30 minutes after a meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven intra- or extrahepatic cholangiocarcinoma, papilla of the Vater or gallbladder carcinoma.
- PS 0-2
- Age 18-75
- Life expectancy > 12 weeks
- Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
Key exclusion criteria (6 listed)
- Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
- Experimental therapy < 8 weeks prior to inclusion
- Uncontrolled, severe concurrent medical disease
- Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
- Allergy to gemcitabine, oxaliplatin or capecitabine
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 |
|---|---|---|
| Gemcitabine | Drug | – |
| Oxaliplatin | Drug | – |
| Capecitabine | Drug | – |
Primary outcome
Response
3 secondary outcomes
Safety
Time to progression
SUrvival
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 26 Aug 2008.
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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.
Ulrik Lassen, MD., PH.D. principal investigator
Rigshospitalet, Dept. of Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine, Oxaliplatin and Capecitabine in people with Cholangiocarcinoma, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 13 inclusion and 6 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 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Response. 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 26 Aug 2008.