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A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026803
Recruitment Status : Terminated (Due to Sorafenib became first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue to support)
First Posted : January 20, 2017
Results First Posted : March 10, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
City of Hope Medical Center

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

Condition or disease Intervention/treatment Phase
Liver Cancer Hepatocellular Cancer Drug: Oxaliplatin Drug: Capecitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer
Study Start Date : November 2006
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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 Name: Eloxatin

Drug: Capecitabine
Given PO
Other Name: Xeloda




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026803


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Sanofi
Investigators
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Principal Investigator: Yun Yen, MD City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03026803    
Other Study ID Numbers: 05195
First Posted: January 20, 2017    Key Record Dates
Results First Posted: March 10, 2017
Last Update Posted: April 13, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Oxaliplatin
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents