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Status:

COMPLETED

SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Liver Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well SB-71...

Detailed Description

OBJECTIVES: * Determine the efficacy of SB-715992, in terms of response rate and stable disease rate, in patients with locally advanced, recurrent, or metastatic hepatocellular carcinoma. * Determine...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed hepatocellular carcinoma
  • Locally advanced, recurrent, or metastatic disease
  • Histologically confirmed disease must have archival paraffin-fixed tumor specimen available
  • Measurable disease
  • At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan
  • Outside of previously irradiated area
  • Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field
  • Bone metastases are not considered measurable disease
  • Not curable by standard therapies
  • No cholangiocarcinoma
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 12 weeks
  • Hematopoietic
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 80,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 5 times ULN
  • Must have hepatic reserve of Child-Turcotte-Pugh class A or better
  • Renal
  • Creatinine clearance ≥ 60 mL/min
  • Cardiovascular
  • No myocardial infarction within the past 6 months
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No active cardiomyopathy
  • No uncontrolled hypertension
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No clinical evidence of encephalopathy
  • No ongoing or active infection
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered
  • Documented disease progression
  • No prior systemic chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy
  • Surgery
  • At least 4 weeks since prior major surgery
  • Prior liver transplantation allowed
  • Other
  • No other prior systemic therapy
  • At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or ethanol injection) and recovered
  • Documented disease progression
  • More than 28 days since prior investigational agents
  • More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
  • Clarithromycin
  • Erythromycin
  • Troleandomycin
  • Itraconazole
  • Ketoconazole
  • Fluconazole (dose \> 200 mg/day)
  • Voriconazole
  • Nefazodone
  • Fluvoxamine
  • Verapamil
  • Diltiazem
  • Grapefruit juice
  • Bitter orange
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Oxcarbazepine
  • Rifampin
  • Rifabutin
  • Rifapentine
  • Hypericum perforatum (St. John's wort)
  • Modafinil
  • At least 6 months since prior and no concurrent amiodarone
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    March 8 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 22 2008

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT00095992

    Start Date

    March 8 2005

    End Date

    September 22 2008

    Last Update

    August 4 2023

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    2

    Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, Canada, L8V 5C2

    3

    Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, Canada, K7L 5P9

    4

    Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, Canada, M5G 2M9