NCT00058487

Brief Summary

RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide in treating patients who have unresectable or metastatic liver cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

December 1, 2001

Completed
1.3 years 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
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

July 18, 2013

Status Verified

October 1, 2006

First QC Date

April 7, 2003

Last Update Submit

July 17, 2013

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomaadvanced adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (2)

  • Antitumor activity

  • Toxic effects

Interventions

epirubicin hydrochlorideDRUG
thalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of hepatocellular carcinoma * Locally unresectable or metastatic disease * Measurable disease * No clinically apparent CNS metastases * No carcinomatous meningitis PATIENT CHARACTERISTICS: Age * Over 18 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 * SGOT no greater than 5 times upper limit of normal * Bilirubin no greater than 3.0 mg/dL * INR no greater than 1.5\* * Albumin at least 2.0 g/dL NOTE: \*Not required for patients receiving full anticoagulation with warfarin for deep vein thrombosis or pulmonary embolism Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * LVEF normal by echocardiogram or MUGA Other * Not pregnant or nursing * Fertile patients must use effective contraception * Willing and able to participate in the System for Thalidomide Education and Prescribing Safety (STEPS) program * No uncontrolled serious medical or psychiatric illness * No other concurrent uncontrolled malignancy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 1 prior chemotherapy regimen for hepatocellular carcinoma * No prior chemoembolization to the liver Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * More than 2 weeks since prior major surgery

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

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Zhu AX, Fuchs CS, Clark JW, Muzikansky A, Taylor K, Sheehan S, Tam K, Yung E, Kulke MH, Ryan DP. A phase II study of epirubicin and thalidomide in unresectable or metastatic hepatocellular carcinoma. Oncologist. 2005 Jun-Jul;10(6):392-8. doi: 10.1634/theoncologist.10-6-392.

    PMID: 15967833RESULT

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

EpirubicinThalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Andrew X. Zhu, MD, PhD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

December 1, 2001

Study Completion

January 1, 2007

Last Updated

July 18, 2013

Record last verified: 2006-10

Locations

US(2)