Clinical trial · Interventional
Oxaliplatin in Treating Patients With Liver Cancer
A Phase II Study of Oxaliplatin in Hepatocellular Cancer
NCT00052364CI-TRIAL-00010762completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have unresectable, recurrent or metastatic liver cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (oxaliplatin)
- description
- Patients receive oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: oxaliplatin
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Up to 6 years
- description
- Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.
- measure
- Time to progression
- timeFrame
- Up to 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed HCC 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 \>= 100,000/μl * Total bilirubin \< 3.0 g/dl * AST(SGOT)/ALT(SGPT) =\< 5 X institutional upper limit of normal * Creatinine \< 2.0 OR measured 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 * The effects of oxaliplatin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because DNA alkylating agents are known to be teratogenic, women of child-bearing 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 * Because the risk of toxicity in nursing infants secondary to oxaliplatin treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued if the mother is treated with oxaliplatin * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patient has prior oxaliplatin 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
References
Publications (0)
Data not yet available
No reference posted for this study.