A Phase II Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer
Overview
- Phase
- Phase 2
- Intervention
- Oxaliplatin
- Conditions
- Liver Cancer
- Sponsor
- City of Hope Medical Center
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Response Rate
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
This phase II trial is studying how well giving oxaliplatin and capecitabine together works in treating patients with liver cancer.
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.
Investigators
Eligibility 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
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.
Arms & Interventions
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
Intervention: Oxaliplatin
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
Intervention: Capecitabine
Outcomes
Primary Outcomes
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