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Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073839
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : September 18, 2015
Information provided by (Responsible Party):
Bernhard Pestalozzi, University of Zurich

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Cholangiocellular Carcinoma Drug: Cisplatin and Gemcitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.
Study Start Date : August 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Cisplatin plus Gemcitabine
Patients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine.
Drug: Cisplatin and Gemcitabine
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.
Other Names:
  • Gemzar
  • Platinol

Primary Outcome Measures :
  1. Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. Histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). Carcinomas involving the gall bladder are allowed.
  2. Macroscopically complete resection within 8 weeks before start of chemotherapy.
  3. Written informed consent.
  4. Health status: WHO performance status (PS) 0-1
  5. Age >18 years
  6. Adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to the formula of Cockcroft-Gault)
  7. Adequate hepatic function (bilirubin ≤ 3 x LUN, AP ≤ 5 x LUN, ASAT ≤ 5 x LUN)
  8. Adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, Hb ≥ 9,5 mg/dl
  9. Patient compliance and geographic proximity allowing proper staging, treatment and follow-up.
  10. 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.

Exclusion criteria

  1. Pregnancy or breastfeeding women
  2. Previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
  3. neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, Hb < 9,5 mg/dl
  4. bilirubin > 3 x LUN, ALAT > 5 x LUN, ASAT > 5 x LUN
  5. Creatinine clearance < 60 ml/min, calculated according to the formula of Cockcroft-Gault
  6. Prior chemotherapy with gemcitabine
  7. 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)
  8. Psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
  9. Active uncontrolled infection
  10. Preexisting peripheral neuropathy (> grade 1)
  11. 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)
  12. Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
  13. Known hypersensitivity to the study drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073839

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Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bernhard Pestalozzi, Prof. Dr. med., University of Zurich Identifier: NCT01073839    
Other Study ID Numbers: ONK USZ 001-2008
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs