Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Etoposide

Oxaliplatin

Capecitabine

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Etoposide, Oxaliplatin, Capecitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml PS 0-2 Age 18-75 Life expectancy > 12 weeks Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l) Bilirubin < 2 x UNL Transaminases < 3 x UNL Normal renal function, Cr-EDTA clearance > 50 ml/min No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion No uncontrolled, severe concurrent medical disease Fertile women must have a negative pregnancy test Fertile women must use adequate contraceptives during and 3 months after trial exposure Signed informed consent Exclusion Criteria: Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion Experimental therapy < 8 weeks prior to inclusion Known DPD-deficiency Known neuropathy Uncontrolled, severe concurrent medical disease Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.

Sites / Locations

Århus Sygehus, Dept. of Oncology

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Time to progression

Safety

Survival

Full Information

NCT ID

NCT00351195

First Posted

July 11, 2006

Last Updated

August 25, 2008

Sponsor

Rigshospitalet, Denmark

Collaborators

Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus

1. Study Identification

Unique Protocol Identification Number

NCT00351195

Brief Title

Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)

Official Title

A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Terminated

Why Stopped

Did not meet the criteria for continuation to second stage

Study Start Date

February 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus

4. Oversight

5. Study Description

Brief Summary

Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but response rates have been low with significant toxicity, most often due to parenchymal liver disease. The three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as single agents, but the combination may act synergistically with an acceptable toxicity profile.

Detailed Description

Design: Open phase II study. Purpose: Response rate for the combination of etoposide, oxaliplatin and capecitabine given every 3 weeks on an outpatient basis. Secondary endpoint are safety, time to progression and survival Treatment: Etoposide are administered intravenously 100 mg/m2 on day 1 and orally 200 mg/m2 on days 2 and 3. Capecitabine (Xeloda) are administered 1000 mg/m2 twice daily with 12 hours interval for two weeks and one week off Oxaliplatin are administered intravenously 100 mg/m2 on day 1 in each cycle as a 2 hours infusion. One cycle is 3 weeks.

6. Conditions and Keywords

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

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, Etoposide, Oxaliplatin, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Primary Outcome Measure Information:

Title

Response

Secondary Outcome Measure Information:

Title

Time to progression

Title

Safety

Title

Survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml PS 0-2 Age 18-75 Life expectancy > 12 weeks Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l) Bilirubin < 2 x UNL Transaminases < 3 x UNL Normal renal function, Cr-EDTA clearance > 50 ml/min No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion No uncontrolled, severe concurrent medical disease Fertile women must have a negative pregnancy test Fertile women must use adequate contraceptives during and 3 months after trial exposure Signed informed consent Exclusion Criteria: Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion Experimental therapy < 8 weeks prior to inclusion Known DPD-deficiency Known neuropathy Uncontrolled, severe concurrent medical disease Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrik Lassen, MD., PH.D.

Organizational Affiliation

Rigshospitalet, Dept. of Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Århus Sygehus, Dept. of Oncology

City

Århus

ZIP/Postal Code

8000 C

Country

Denmark

Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial