Oxaliplatin in Treating Patients With Liver Cancer

NCT00052364 | Completed Phase 2

• 3 other identifiers: NCI-2012-02830PHII-36N01CM17101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 6 years

• Time to progression

  Up to 6 years

Secondary Outcomes (2)

• Duration of overall survival

  Up to 6 years

• Progression-free survival

  Up to 6 years

Study Arms (1)

Treatment (oxaliplatin)

EXPERIMENTAL

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.

Drug: oxaliplatin; Other: laboratory biomarker analysis

Interventions

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Treatment (oxaliplatin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (oxaliplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Yun Yen

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: January 1, 2006
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)