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Status:

WITHDRAWN

Celecoxib and Erlotinib in Treating Patients With Liver Cancer

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Liver Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Celecoxib may also stop the growth of liver cancer by blocking blood flow...

Detailed Description

OBJECTIVES: Primary * Determine the safety of adjuvant celecoxib and erlotinib hydrochloride for patients with hepatocellular carcinoma (HCC) at high risk for recurrence. (phase I) * Assess disease-...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histological evidence of hepatocellular carcinoma (HCC)
  • No evidence of residual or recurrent disease
  • Received 1 of the following therapies:
  • Tumor resection between 4-8 weeks prior to study enrollment
  • Transarterial chemo-embolization between the past 4-8 weeks
  • Radiofrequency ablation and percutaneous ethanol injection (sequential or combinations thereof) between the past 2-8 weeks
  • Meets 1 of the following high-risk features for recurrence:
  • History of resection of a single HCC \> 5 cm
  • History of multifocal HCC (includes microsatellite disease found at time of resection)
  • History of vascular invasion (macro or micro)
  • History of poorly differentiated HCC
  • Underlying cirrhosis
  • No Child-Pugh class C cirrhosis
  • PATIENT CHARACTERISTICS:
  • Absolute neutrophil count \> 1,500/mm\^3
  • Platelet count ≥ 75,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST/ALT ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • INR ≤ 1.5 times ULN
  • Albumin ≥ 2.5 g/dL
  • ECOG performance status 0-2
  • Life expectancy ≥ 2 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • Patients must agree not to wear contact lenses
  • No history of ulcer disease or gastrointestinal bleeding
  • No myocardial infarction within the past 18 months
  • No cerebral vascular event within the past 18 months
  • No history of aspirin or NSAID-induced asthma
  • No history of Gilbert's syndrome
  • No history of hypersensitivity reaction or allergy to sulfa drugs, aspirin, or other NSAIDs
  • No liver transplantation candidates for phase I portion of the study
  • No New York Heart Association class III or IV cardiac disease
  • No interstitial lung disease
  • No gastrointestinal disease prohibiting oral medication or requiring IV alimentation
  • No active peptic ulcer disease
  • No unstable angina pectoris
  • No ongoing, active, or untreated infection
  • No hypersensitivity to celecoxib
  • No rising alpha-fetal protein (AFP) not attributable to hepatitis B or C virus
  • No psychiatric illness or social situation that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • No prior liver transplantation
  • No prior chemotherapy or biologic therapy in the adjuvant setting
  • No prior chest or mantle radiotherapy
  • No concurrent aspirin or other nonsteroidal anti-inflammatory drug (NSAID)
  • No concurrent interferon
  • No concurrent oral steroids
  • No concurrent anticoagulant therapy
  • No concurrent CYP3A4 inducers or inhibitors
  • No concurrent commercial or other investigational anticancer agents or therapies
  • No concurrent selective cyclooxygenase-2 inhibitors
  • No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00293436

    Start Date

    January 1 2005

    Last Update

    September 17 2012

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    UCSF Comprehensive Cancer Center

    San Francisco, California, United States, 94115