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Oxaliplatin in Treating Patients With Liver Cancer

Primary Purpose

Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oxaliplatin)

Arm 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.

Outcomes

Primary Outcome Measures

Response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.
Time to progression

Secondary Outcome Measures

Duration of overall survival
Estimated using the product-limit method of Kaplan and Meier.
Progression-free survival
Estimated using the product-limit method of Kaplan and Meier.

Full Information

First Posted
January 24, 2003
Last Updated
June 17, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052364
Brief Title
Oxaliplatin in Treating Patients With Liver Cancer
Official Title
A Phase II Study of Oxaliplatin in Hepatocellular Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: I. To assess response rate and progression free survival in patients with hepatocellular cancer treated with oxaliplatin. II. To assess the toxicity and tolerance of oxaliplatin in patient with hepatocellular cancer. III. To evaluate the mRNA expression of enzymes in tumors of the patients entered on this study which may be important to the cytotoxicity of oxaliplatin (ERCC1, mismatch repair, ribonucleotide reductase, bcl-2, bax, p53). An attempt will be made to obtain tumor biopsies from all patients. OUTLINE: This is a multicenter study. Patients are stratified according to presence of the fibrolamellar variant of hepatocellular cancer (yes vs no). 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. Patients are followed for survival. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oxaliplatin)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
Description
Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.
Time Frame
Up to 6 years
Title
Time to progression
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Duration of overall survival
Description
Estimated using the product-limit method of Kaplan and Meier.
Time Frame
Up to 6 years
Title
Progression-free survival
Description
Estimated using the product-limit method of Kaplan and Meier.
Time Frame
Up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Yen
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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Oxaliplatin in Treating Patients With Liver Cancer

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