RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have unresectable, recurrent or metastatic liver cancer.

Condition	Treatment or Intervention	Phase
advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma	Drug: oxaliplatin  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine response rate and progression-free survival of patients with hepatocellular cancer treated with oxaliplatin.
• Determine the toxicity and tolerability of this drug in these patients.
• Determine whether mRNA expression of enzymes in tumors of these patients is related to the cytotoxicity of this drug.

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed hepatocellular cancer
• Recurrent, metastatic, or unresectable disease
• Progressive disease
• Unidimensionally measurable disease
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Pleural effusions and ascites not considered measurable, but may be present
• Brain metastases allowed only if controlled by surgery or stereotactic radiotherapy

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 2 months

Hematopoietic

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin less than 3.0 mg/dL
• AST/ALT no greater than 5 times upper limit of normal

Renal

• Creatinine less than 2.0 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Pulmonary

• No pulmonary fibrosis
• No pulmonary interstitial process

Other

• No clinically significant neuropathy
• No allergy to platinum compounds or to antiemetics used in study
• No HIV-positive patients receiving antiretroviral therapy
• No ongoing or active infection
• No other concurrent uncontrolled illness
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent colony-stimulating factors during first course of study

Chemotherapy

• No prior oxaliplatin
• No more than 2 prior chemotherapy regimens
• At least 4 weeks since prior chemoembolization
• At least 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 4 weeks since prior alcohol injections
• At least 4 weeks since prior therapy
• No other concurrent investigational agents
• No other concurrent investigational or commercial agents or therapies to treat this malignancy

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States; Recruiting
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Study ID Numbers:  CDR0000258202; CCC-PHII-36; CHNMC-PHII-36; NCI-5589; NCT00052364
Record last reviewed:  July 2004
Last Updated:  December 6, 2004
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052364
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08