Celecoxib and Erlotinib in Treating Patients With Liver Cancer

NCT00293436 | Withdrawn Phase 1

• 3 other identifiers: CDR0000458055UCSF-04459UCSF-H43059-26066-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving celecoxib together with erlotinib and to see how well they work in treating patients with liver cancer.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized resectable adult primary liver cancer

Outcome Measures

Primary Outcomes (2)

• Safety (phase I)

• Disease-free survival (phase II)

Secondary Outcomes (2)

• Maximum tolerated dose (phase I)

• Overall survival (phase II)

Interventions

celecoxib DRUG

erlotinib hydrochloride DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Celecoxib; Erlotinib Hydrochloride; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Alan P. Venook, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: January 1, 2005
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

US (1)