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Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

Primary Purpose

Cholangiocellular Carcinoma

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

Cisplatin and Gemcitabine

About this trial

This is an interventional treatment trial for Cholangiocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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.
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

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cisplatin plus Gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease-free survival

Full Information

NCT ID

NCT01073839

First Posted

June 25, 2009

Last Updated

September 17, 2015

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01073839

Brief Title

Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

Official Title

Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin plus Gemcitabine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin and Gemcitabine

Other Intervention Name(s)

Gemzar, Platinol

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

One year

Secondary Outcome Measure Information:

Title

Disease-free survival

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria 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. 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

01 Studienregister MasterAdmins

Organizational Affiliation

UniversitaetsSpital Zuerich

Official's Role

Study Director

Facility Information:

City

Zurich

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

29325521

Citation

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.

Results Reference

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Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

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