Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
Bernhard Pestalozzi, University of Zurich
ClinicalTrials.gov Identifier:
NCT01073839
First received: June 25, 2009
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention Phase
Cholangiocellular Carcinoma
Drug: Cisplatin and Gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

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

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073839

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Bernhard Pestalozzi, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT01073839     History of Changes
Other Study ID Numbers: ONK USZ 001-2008
Study First Received: June 25, 2009
Last Updated: March 21, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Cholangiocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Gemcitabine
Cisplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014