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Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

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ClinicalTrials.gov Identifier: NCT01073839
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : September 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bernhard Pestalozzi, University of Zurich

Tracking Information
First Submitted Date  ICMJE June 25, 2009
First Posted Date  ICMJE February 23, 2010
Last Update Posted Date September 18, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2010)
Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2010)
Disease-free survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.
Official Title  ICMJE Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.
Brief 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 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholangiocellular Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Cisplatin plus Gemcitabine
Patients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine.
Intervention: Drug: Cisplatin and Gemcitabine
Publications * Siebenhüner 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2015)
33
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2010)
30
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01073839
Other Study ID Numbers  ICMJE ONK USZ 001-2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernhard Pestalozzi, University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP