NCT00003296

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with liver or bile duct cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 8, 2004

Completed
Last Updated

December 19, 2013

Status Verified

September 1, 2000

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Extrahepatic Bile Duct CancerGallbladder CancerLiver Cancer

Keywords

localized resectable adult primary liver cancerlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancerlocalized gallbladder cancerunresectable gallbladder cancerrecurrent gallbladder cancerlocalized extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct canceradult primary hepatocellular carcinomacholangiocarcinoma of the gallbladdercholangiocarcinoma of the extrahepatic bile ductadult primary cholangiocellular carcinoma

Interventions

filgrastimBIOLOGICAL
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the liver or bile ducts including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer Measurable or evaluable disease by CT scan (ascites, pleural effusions, and bone metastases are not considered evaluable) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 mg/dL No severe cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Left ventricular cardiac ejection fraction at least 45% Other: No allergy to egg or egg products Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior doxorubicin At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (2)

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Brown University Oncology Group

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Bile Duct NeoplasmsGallbladder NeoplasmsLiver NeoplasmsCarcinoma, Hepatocellular

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Howard Safran, MD

    Brown University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 8, 2004

Study Start

January 1, 1998

Last Updated

December 19, 2013

Record last verified: 2000-09

Locations

US(2)