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Oxaliplatin in Treating Patients With Liver Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052364
  Purpose

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 Intervention Phase
Liver Cancer
Drug: oxaliplatin
Phase II

MedlinePlus related topics: Cancer Liver Cancer
Drug Information available for: Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Oxaliplatin In Hepatocellular Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052364

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000258202, CCC-PHII-36, CHNMC-PHII-36, NCI-5589
Study First Received: January 24, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00052364  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Study placed in the following topic categories:
Liver Neoplasms
Oxaliplatin
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Recurrence
Hepatocellular carcinoma
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009