NCT00006016

Brief Summary

This phase II trial is studying the effectiveness of combining thalidomide and chemoembolization in treating patients who have liver cancer that cannot be removed by surgery. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Combining thalidomide with chemoembolization may kill more tumor cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2000

Longer than P75 for phase_2

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

May 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

April 15, 2015

Status Verified

January 1, 2013

Enrollment Period

4.9 years

First QC Date

July 5, 2000

Last Update Submit

April 14, 2015

Conditions

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Survival

    The survival distribution will be estimated using the Kaplan-Meier method, with corresponding 95% confidence intervals.

    Up to 18 months

Study Arms (1)

Treatment (thalidomide, chemoembolization)

EXPERIMENTAL

Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure. Thalidomide administration is stopped 24 hours before each chemoembolization procedure, and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever occurs later. Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance. Immediately after delivery of the chemoemulsion, patients undergo particulate embolization. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization.

Drug: thalidomideDrug: doxorubicin hydrochlorideOther: laboratory biomarker analysis

Interventions

thalidomideDRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid
Treatment (thalidomide, chemoembolization)
doxorubicin hydrochlorideDRUG

Given transarterially (chemoembolization)

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Treatment (thalidomide, chemoembolization)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (thalidomide, chemoembolization)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven hepatocellular carcinoma
  • Ineligible for potentially curative surgical resection
  • Must be a candidate for palliative chemoembolization
  • MRI must show one or more discrete tumor nodules that can be targeted by angiography for chemoembolization
  • No diffusely infiltrating tumor
  • Lesions under consideration for chemoembolization must demonstrate substantial hypervascularity
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 1,200/mm\^3
  • Hemoglobin at least 8.0 g/dL
  • Platelet count at least 50,000/mm\^3
  • SGOT and SGPT no greater than 5 times normal
  • Bilirubin less than 3 mg/dL
  • Creatinine no greater than 1.5 mg/dL
  • No other medical condition that would preclude study participation
  • No other malignancy within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

ThalidomideDoxorubicin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Alec Goldenberg

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

May 1, 2000

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

April 15, 2015

Record last verified: 2013-01

Locations

US(1)