Advanced or Metastatic Cholangiocellular Carcinoma and Bile DuctPhase 2NCT01153750
Efficacy of Imatinib and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct
A Phase 2 study testing Glivec in people with Advanced or Metastatic Cholangiocellular Carcinoma and Bile Duct, run by University Hospital Dresden at 8 sites in Germany.
Trial summary
To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Cholangiocellular Carcinoma and Bile Duct
- What is being tested?
- Glivec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 8 sitesGermany
- Study dates
- Apr 2007to Mar 2010
- 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/Cytologically confirmed diagnosis of advanced / metastatic carcinoma of the gallbladder or bile duct, which is unresectable or metastatic and therefore incurable with any conventional multimodality approach
- Performance status 0, 1 or 2 (ECOG)
- Written, voluntary informed consent
- Age > 18 years
- Adequate bone marrow function (Granulocytes > 1,5 x 109/l, Hb > 10 g/dl, Platelets > 100 x 109/l)
- Adequate hepatic and renal function ( bilirubin < 1,25 x upper normal limit or < 1,5 x upper normal limit if hyperbilirubinemia is related to underlying disease, ALAT + ASAT < 1,5 x upper normal limit, in case of liver metastases < 5 x upper normal limit, creatinine < 1,25 x upper normal limit)
- Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Female patients with child-bearing potential must perform a highly effective barrier method of birth control throughout the study with a proven efficacy of >99%. The contraception treatment should be performed for an additional six month following discontinuation from study treatment. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following discontinuation of study drug.
Who cannot join
- Patient has received any other investigational agents within 28 days of first day of study drug dosing.
- Patient is < 5 years free of another primary malignancy, except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
- Female patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled medical disease.
- The concurrent use of warfarin or acetaminophen are not allowed with imatinib mesylate and need to be replaced by other medications (e.g. by low molecular heparins in case of warfarin).
- Radiotherapy or any major abdominal or thoracic surgery < 4 weeks before study entry (excluding diagnostic biopsy or port implantation)
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- Patient has received neoadjuvant imatinib mesylate or fluoropyrimidines prior to study entry
- Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- Known incompatibility of imatinib,5-FU, or leucovorin
- Known brain metastases
- Concurrent systemic chemotherapy, immunotherapy, hormone therapy
- History of severe psychiatric illness
- Drug- or alcohol abuse
- Patient has know chronic liver disease (i.e., chronic active hepatitis, and cirrhosis)
- Patients with dihydropyrimidine dehydrogenase deficiency (i.e. Treatment with Zostex)
- Patients that are associated with or dependent of the investigator or sponsor
- Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- Patients with a creatinine clearance of < 50ml/min.
- Patients with a severe decrease of bone marrow function
- Patients with acute infections
- Patients with severe decrease of liver function
- Patients in reduced performance status (ECOG > 2)
- No active vaccinations should be performed while being on study treatment
- Anemia caused by vitamin B12 deficiency
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
University Hospital
Dresden, Saxony, 01307
Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, 20249
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Staedtisches Klinikum Magdeburg
Magdeburg, 36130
Johannes-Gutenberg-Universität Mainz, Medical Department I
Mainz, 55131
Ruppiner Kliniken GmbH
Neuruppin, 16816
Praxisgemeinschaft Dr. Hancken und Partner
Stade, 21680
About this study
Official title: Phase II Study to Evaluate the Efficacy of a Chemotherapy Combination With Imatinib (Glivec®) and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct
To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma.
Read the detailed description
Efficacy: Tumor assessments should be performed by a CT or MRI scan, throughout the study. All assessments should be performed within 14 days of the scheduled day according to the visit schedules, and whenever clinically indicated otherwise. Radiological studies must use the same techniques as used at baseline. Evaluation will be based on RECIST criteria.
Safety: Safety assessments will consist of evaluating adverse events and serious adverse events, laboratory parameters including hematology, chemistry, vital signs, physical examinations, and documentation of all concomitant medications and/or therapies.
- Being tested
- Glivec
- Keywords
- cholangiocellular carcinoma, bile duct cancer
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlivecDrug
| Study group | Role | What they receive |
|---|---|---|
| Glivec and 5-Fluorouracil/Leucovorin | Experimental | All patients will receive Glivec® 600 mg once daily without dose escalation. Glivec® will be given on day -4, -3, -2, -1, 1, 2, 3 and 4. There will be no day "0". Patients will also receive 5-FU (2000mg/qm 24hc.i. d1 + d2) and leucovorin (200mg/qm 2h-infusion) qd15. Receives: Drug: Glivec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Secondary outcomes (5)
Progression-free survival (PFS)
Response rate (RR)
Overall survival
Toxicity
Evaluation of molecular predictive markers for response and toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startApr 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Cholangiocellular Carcinoma and Bile DuctStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Jan Stoehlmacher, PD Dr., Principal investigator, University Hospital Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153750
- Sponsor's protocol ID
- TUD-Glivec-012
- Status last verified
- Apr 2010
- First submitted
- 1 Apr 2010
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy of a Chemotherapy Combination With Imatinib (Glivec®) and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct
- ClinicalTrials.gov ID
- NCT01153750
- Acronym / sponsor ID
- TUD-Glivec-012
- Keywords
- cholangiocellular carcinoma, bile duct cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital DresdenUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Jun 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.
To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma.
Detailed description
Efficacy: Tumor assessments should be performed by a CT or MRI scan, throughout the study. All assessments should be performed within 14 days of the scheduled day according to the visit schedules, and whenever clinically indicated otherwise. Radiological studies must use the same techniques as used at baseline. Evaluation will be based on RECIST criteria.
Safety: Safety assessments will consist of evaluating adverse events and serious adverse events, laboratory parameters including hematology, chemistry, vital signs, physical examinations, and documentation of all concomitant medications and/or therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glivec and 5-Fluorouracil/Leucovorin | Experimental | Drug: GlivecAll patients will receive Glivec® 600 mg once daily without dose escalation. Glivec® will be given on day -4, -3, -2, -1, 1, 2, 3 and 4. There will be no day "0". Patients will also receive 5-FU (2000mg/qm 24hc.i. d1 + d2) and leucovorin (200mg/qm 2h-infusion) qd15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically/Cytologically confirmed diagnosis of advanced / metastatic carcinoma of the gallbladder or bile duct, which is unresectable or metastatic and therefore incurable with any conventional multimodality approach
- Performance status 0, 1 or 2 (ECOG)
- Written, voluntary informed consent
- Age > 18 years
- Adequate bone marrow function (Granulocytes > 1,5 x 109/l, Hb > 10 g/dl, Platelets > 100 x 109/l)
Key exclusion criteria (24 listed)
- Patient has received any other investigational agents within 28 days of first day of study drug dosing.
- Patient is < 5 years free of another primary malignancy, except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
- Female patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled medical disease.
- The concurrent use of warfarin or acetaminophen are not allowed with imatinib mesylate and need to be replaced by other medications (e.g. by low molecular heparins in case of warfarin).
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 |
|---|---|---|
| Glivec | Drug | Glivec and 5-Fluorouracil/Leucovorin |
Primary outcome
Disease Control Rate (DCR)
5 secondary outcomes
Progression-free survival (PFS)
Response rate (RR)
Overall survival
Toxicity
Evaluation of molecular predictive markers for response and toxicity
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 30 Jun 2010.
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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.
Jan Stoehlmacher, PD Dr. principal investigator
University Hospital Dresden
8 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 Glivec in people with Advanced or Metastatic Cholangiocellular Carcinoma and Bile Duct, run by University Hospital Dresden at 8 sites in Germany.
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 7 inclusion and 24 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 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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?
Disease Control Rate (DCR). 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 30 Jun 2010.