search
Back to results

Celecoxib and Erlotinib in Treating Patients With Liver Cancer

Primary Purpose

Liver Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
erlotinib hydrochloride
adjuvant therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Safety (phase I)
Disease-free survival (phase II)

Secondary Outcome Measures

Maximum tolerated dose (phase I)
Overall survival (phase II)

Full Information

First Posted
February 16, 2006
Last Updated
September 13, 2012
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00293436
Brief Title
Celecoxib and Erlotinib in Treating Patients With Liver Cancer
Official Title
A Phase I/II Study of Celecoxib and Erlotinib Hydrochloride as Adjuvant Therapy for High Risk Patients With a History of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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-free and overall survival of patients treated with adjuvant celecoxib and erlotinib hydrochloride. (phase II) Secondary Determine the maximum tolerated dose of celecoxib and erlotinib hydrochloride for the phase II portion of this trial. (phase I) OUTLINE: This is a phase I, dose-escalation study followed by an open-label, phase II study. Patients are assigned to a treatment according to Child-Pugh class of cirrhosis (class A/noncirrhotic vs class B). Phase I: Patients receive oral celecoxib once or twice daily and oral erlotinib hydrochloride once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of celecoxib and erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Separate dose escalations are conducted in the 2 groups according to liver dysfunction. Phase II: Patients receive celecoxib and erlotinib hydrochloride as in phase I at the MTD. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Safety (phase I)
Title
Disease-free survival (phase II)
Secondary Outcome Measure Information:
Title
Maximum tolerated dose (phase I)
Title
Overall survival (phase II)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan P. Venook, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Celecoxib and Erlotinib in Treating Patients With Liver Cancer

We'll reach out to this number within 24 hrs