A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

March 16, 2017 updated by: City of Hope Medical Center

A Phase II Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

This phase II trial is studying how well giving oxaliplatin and capecitabine together works in treating patients with liver cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving these drugs together may kill more tumor cells.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologically confirmed hepatocellular carcinoma which is recurrent, metastatic or unresectable.
  • Patients may have up to two prior chemotherapy regimes. In addition, they may have had previous radiation, chemoembolization, and/or alcohol injections.
  • Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, and which has clearly progressed during the observation interval prior to participation in this study. Pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s).
  • Karnofsky performance status > 70%.
  • Patients should have an expected survival of at least 2 months.
  • Leukocytes >3,000/µl
  • Absolute neutrophil count >1,500/µl
  • Platelets >50,000/µl
  • Total bilirubin < 3.0 g/dl
  • AST (aspartate aminotransferase) (serum glutamic oxaloacetic transaminase(SGOT)/ALT (alanine aminotransferase) (serum glutamic pyruvic transaminase)(SGPT) < 5 times institutional upper limit of normal
  • Creatinine < 2.0 OR measured or calculated creatinine clearance >60 mL/min for patients with creatinine levels above institutional normal
  • Brain metastasis is not an exclusion, however, patients are only eligible if they have had successful control of the brain tumor(s) by surgery or stereotactic RT.
  • Patients with no evidence of clinically significant neuropathy.
  • All prior therapy must have been completed at least 4 weeks prior to the patient's entry on this trial.
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Breastfeeding should be discontinued if the mother is treated with oxaliplatin.
  • Subjects with chronic hepatitis B or C may be undergoing treatment with α interferon and/or ribavirin, as long as they meet the other criteria for entry on to this study.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients have prior oxaliplatin or xeloda treatment or undergoing therapy with other investigational agents.
  • History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
  • HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions.
  • Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process.
  • Patients unable to swallow capecitabine will be excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxaliplatin and Capecitabine
21 day cycle with Oxaliplatin 50mg/m2 day 1 and day 8 administered IV, Capecitabine 750 mg/m2 bid p.o. daily from day 1 to day 14
Drug: Oxaliplatin
Given IV
Other Names:
  • Eloxatin
Drug: Capecitabine
Given PO
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: Up to 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

Sanofi

Investigators

  • Principal Investigator: Yun Yen, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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