A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03026803
• Other study ID #: 05195
• Status: Terminated
• Phase: Phase 2
• First received: January 17, 2017
• Last updated: January 18, 2017
• Start date: November 2006
• Est. completion date: October 2014

Study information

• Verified date: January 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a 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.

Related Conditions & MeSH terms

• Hepatocellular Cancer
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• Oxaliplatin
Given IV
• Capecitabine
Given PO

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		Up to 2 years
Primary	Progression free survival		Up to 2 years
Primary	Incidence of toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0		30 days after last treatment
Secondary	Change in mRNA (messenger ribonucleic acid) expression of enzymes in tumors that may be important to cytotoxicity of oxaliplatin (ERCC1, XPA, GADD45ß, mismatch repair, ribonucleotide reductase, bcl-2, bax, p53)		Up to 2 years