Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

NCT01073839 | Completed Phase 1 DMC

• 1 other identifier: ONK USZ 001-2008
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Cholangiocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0

  One year

Secondary Outcomes (1)

• Disease-free survival

  5 years

Study Arms (1)

Cisplatin plus Gemcitabine

EXPERIMENTAL

Patients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine.

Drug: Cisplatin and Gemcitabine

Interventions

Cisplatin and Gemcitabine DRUG

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.

Also known as: Gemzar, Platinol

Cisplatin plus Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 29325521 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: February 23, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

CH (1)