NCT00057980

Brief Summary

RATIONALE: Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining celecoxib with epirubicin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of epirubicin when given together with celecoxib and to see how well it works in treating patients with hepatocellular carcinoma (liver cancer).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

4.3 years

First QC Date

April 7, 2003

Last Update Submit

June 7, 2012

Conditions

Liver Cancer

Keywords

advanced adult primary liver cancerlocalized unresectable adult primary liver canceradult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (4)

  • Maximum tolerated dose of epirubicin

  • Response rate

  • Survival at 6 months

  • Overall survival

Secondary Outcomes (3)

  • Toxicity profile

  • Serum vascular endothelial growth factor levels in correlation to response

  • Cyclooxygenase-2 expression in tumor tissue and nonmalignant liver tissue in correlation to response

Interventions

celecoxibDRUG
epirubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of localized or metastatic hepatocellular carcinoma (HCC) by 1 of the following: * Biopsy * Alpha-fetoprotein (AFP) measurement (greater than 400 ng/mL if hepatitis B surface antigen \[HBsAg\] is negative OR greater than 1,000 ng/mL if HBsAg is positive) * Not amenable to surgical resection or liver-directed therapy * Measurable or evaluable disease\* NOTE: \*Changes in AFP alone are not sufficient * Child-Pugh score A or B PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic * Bilirubin no greater than 3.0 mg/dL * AST no greater than 5 times upper limit of normal Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * LVEF greater than 45% by MUGA or echocardiogram Other * Not pregnant or nursing * Fertile patients must use effective contraception * No requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) except low-dose (81 mg) aspirin * No known hypersensitivity to aspirin or other NSAIDs * No contraindication to cyclooxygenase-2 (COX-2) inhibitor therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for HCC

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

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

CelecoxibEpirubicin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Mary Mulcahy, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

October 1, 2002

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

US(1)