Cholangiocellular CarcinomaPhase 1/2NCT01073839
Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.
A Phase 1/2 study testing Cisplatin and Gemcitabine in people with Cholangiocellular Carcinoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
OBJECTIVES Primary objective: The primary objective of the trial is to determine the safety of adjuvant treatment with cisplatin plus gemcitabine for a period of 6 months after curative resection of cholangiocellular carcinoma Secondary objectives: Secondary objectives of the trial are to assess the feasibility and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocellular Carcinoma
- What is being tested?
- Cisplatin and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). Carcinomas involving the gall bladder are allowed.
- Macroscopically complete resection within 8 weeks before start of chemotherapy.
- Written informed consent.
- Health status: WHO performance status (PS) 0-1
- Age >18 years
- Adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to the formula of Cockcroft-Gault)
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- Adequate hepatic function (bilirubin ≤ 3 x LUN, AP ≤ 5 x LUN, ASAT ≤ 5 x LUN)
- Adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, Hb ≥ 9,5 mg/dl
- Patient compliance and geographic proximity allowing proper staging, treatment and follow-up.
- Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during participation in the trial or during the 12 months thereafter. A negative pregnancy test before inclusion into the trial is required for women < 50 years. Men who agree not to father a child during participation in the trial or during the 12 months thereafter.
Who cannot join
- Pregnancy or breastfeeding women
- Previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
- neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, Hb < 9,5 mg/dl
- bilirubin > 3 x LUN, ALAT > 5 x LUN, ASAT > 5 x LUN
- Creatinine clearance < 60 ml/min, calculated according to the formula of Cockcroft-Gault
- Prior chemotherapy with gemcitabine
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- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmias)
- Psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
- Active uncontrolled infection
- Preexisting peripheral neuropathy (> grade 1)
- Serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)
- Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
- Known hypersensitivity to the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.
OBJECTIVES
Primary objective:
Read more
The primary objective of the trial is to determine the safety of adjuvant treatment with cisplatin plus gemcitabine for a period of 6 months after curative resection of cholangiocellular carcinoma
Secondary objectives:
Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant therapy and to determine duration of response and patterns of failure compared to historical controls without postoperative treatment
Exploratory objectives:
To obtain blood samples and tumor tissue after resection for establishment and characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are identification of tumor specific antibodies from blood samples, and characterization of tumor antigens with consecutive development of new specific immunological therapies, e.g. cancer-testis antigens (CTA) for tumor vaccination.
- Trial with medicinal product
- Conditions
- Cholangiocellular Carcinoma
- Being tested
- Cisplatin and Gemcitabine
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin and GemcitabineDrug
Also called Gemzar, Platinol
Cisplatin 25 mg/m2 days 1 and 8; next cycle starting day 22. Gemcitabine 1000 mg/m2 days 1 and 8; next cycle starting day 22. Total of 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin plus Gemcitabine | Experimental | Patients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine. Receives: Drug: Cisplatin and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0
Measured: One year
Secondary outcomes (1)
Disease-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholangiocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Pestalozzi, University of Zurich
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073839
- Sponsor's protocol ID
- ONK USZ 001-2008
- Status last verified
- Sep 2015
- First submitted
- 25 Jun 2009
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siebenhuner AR, Seifert H, Bachmann H, Seifert B, Winder T, Feilchenfeldt J, Breitenstein S, Clavien PA, Stupp R, Knuth A, Pestalozzi B, Samaras P. Adjuvant treatment of resectable biliary tract cancer with cisplatin plus gemcitabine: A prospective single center phase II study. BMC Cancer. 2018 Jan 11;18(1):72. doi: 10.1186/s12885-017-3967-0.
PubMed 29325521
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.
- ClinicalTrials.gov ID
- NCT01073839
- Acronym / sponsor ID
- ONK USZ 001-2008
- Conditions
- Cholangiocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Feb 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.
OBJECTIVES
Primary objective:
The primary objective of the trial is to determine the safety of adjuvant treatment with cisplatin plus gemcitabine for a period of 6 months after curative resection of cholangiocellular carcinoma
Secondary objectives:
Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant therapy and to determine duration of response and patterns of failure compared to historical controls without postoperative treatment
Exploratory objectives:
To obtain blood samples and tumor tissue after resection for establishment and characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are identification of tumor specific antibodies from blood samples, and characterization of tumor antigens with consecutive development of new specific immunological therapies, e.g. cancer-testis antigens (CTA) for tumor vaccination.
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin plus Gemcitabine | Experimental | Drug: Cisplatin and GemcitabinePatients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). Carcinomas involving the gall bladder are allowed.
- Macroscopically complete resection within 8 weeks before start of chemotherapy.
- Written informed consent.
- Health status: WHO performance status (PS) 0-1
- Age >18 years
Key exclusion criteria (13 listed)
- Pregnancy or breastfeeding women
- Previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
- neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, Hb < 9,5 mg/dl
- bilirubin > 3 x LUN, ALAT > 5 x LUN, ASAT > 5 x LUN
- Creatinine clearance < 60 ml/min, calculated according to the formula of Cockcroft-Gault
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 |
|---|---|---|
| Cisplatin and GemcitabineAlso: Gemzar, PlatinolCisplatin 25 mg/m2 days 1 and 8; next cycle starting day 22. Gemcitabine 1000 mg/m2 days 1 and 8; next cycle starting day 22. Total of 8 cycles. | Drug | Cisplatin plus Gemcitabine |
Primary outcome
Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0
Time frame: One year
1 secondary outcome
Disease-free survival
Time frame: 5 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 18 Sep 2015.
- Derived from this study: PubMed 29325521Siebenhuner AR, Seifert H, Bachmann H, Seifert B, Winder T, Feilchenfeldt J, Breitenstein S, Clavien PA, Stupp R, Knuth A, Pestalozzi B, Samaras P. Adjuvant treatment of resectable biliary tract cancer with cisplatin plus gemcitabine: A prospective single center phase II study. BMC Cancer. 2018 Jan 11;18(1):72. doi: 10.1186/s12885-017-3967-0.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site 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 Cisplatin and Gemcitabine in people with Cholangiocellular Carcinoma, run by University of Zurich at 1 site in Switzerland.
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 10 inclusion and 13 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 18 Sep 2015. 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 Switzerland. 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?
Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073839, which also lists 1 linked publication.
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 18 Sep 2015.