Oxaliplatin in Treating Patients With Liver Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 24, 2003
Last Updated Date	February 7, 2009
Start Date ^†	September 2002
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00052364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Oxaliplatin in Treating Patients With Liver Cancer
Official Title ^†	A Phase II Study Of Oxaliplatin In Hepatocellular Cancer
Brief Summary	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.
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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Open Label
Condition ^†	Liver Cancer
Intervention ^†	Drug: oxaliplatin
Study Arms / Comparison Groups
Publications *	Yen Y, Lim DW, Chung V, Morgan RJ, Leong LA, Shibata SI, Wagman SD, Marx H, Chu PG, Longmate JA, Lenz HJ, Ramanathan RK, Belani CP, Gandara DR. Phase II study of oxaliplatin in patients with unresectable, metastatic, or recurrent hepatocellular cancer: a California Cancer Consortium Trial. Am J Clin Oncol. 2008 Aug;31(4):317-22.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†
Completion Date
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00052364
Responsible Party
Secondary IDs ^††	CCC-PHII-36, CHNMC-PHII-36, NCI-5589
Study Sponsor ^†	California Cancer Consortium
Collaborators ^††	National Cancer Institute (NCI)
Investigators ^†
Information Provided By	National Cancer Institute (NCI)
Verification Date	April 2005
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.