A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

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City of Hope

Status and phase

Terminated
Phase 2

Conditions

Hepatocellular Cancer
Liver Cancer

Treatments

Drug: Oxaliplatin
Drug: Capecitabine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03026803
05195

Details and patient eligibility

About

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

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

4 participants in 1 patient group

Oxaliplatin and Capecitabine
Experimental group
Description:
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
Treatment:
Drug: Capecitabine
Drug: Oxaliplatin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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