NCT01079767

Brief Summary

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with advanced liver cancer and cirrhosis.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2010

Enrollment Period

11 months

First QC Date

March 2, 2010

Last Update Submit

March 3, 2014

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 (1)

  • 3-month disease-control rate according to RECIST criteria

    2010

Secondary Outcomes (1)

  • 3-month objective response rate according to RECIST criteria

    2010

Study Arms (1)

Temsirolimus

OTHER

Temsirolimus

Drug: temsirolimus

Interventions

temsirolimusDRUG
Temsirolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of the Liver (EASL) criteria * Advanced disease * Must be morphologically evaluable * HCC not accessible to other treatment (e.g., surgery, radiofrequency, or chemoembolization) and can not benefit from antiangiogenic therapy * CLIP score ≤ 3 (except for patients with tumors invading more than 50% of tumor volume) * Child-Pugh cirrhosis score between B7 and B9, meeting the following criteria: * Diagnosed clinically, biologically (e.g., prothrombin time, platelets, or albumin), endoscopically (signs of portal hypertension) and morphologically (dysmorphic liver on ultrasound or CT scan), or by liver biopsy * Not a candidate for transplantation and has not received a liver transplant PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Platelet count ≥ 50,000/mm\^3 * Neutrophil count ≥ 1,500/mm\^3 * Creatinine clearance ≥ 60 mL/min * GFR ≥ 30 mL/min * Serum cholesterol ≤ 350 mg/dL * Triglycerides ≤ 300 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception during and for more than 2 months after completion of study therapy * No history of other cancer on treatment * No cardiopulmonary disease impairment, including a history of stable or unstable angina or myocardial infarction * No active infection except for viral hepatitis * No HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior inhibitors or inducers of P-glycoprotein, CYP3A4, or CYP3A5 * At least 4 weeks since prior surgery, radiotherapy (except radiotherapy to the bone), transarterial chemoembolization, immunotherapy, or other investigational drug for HCC * At least 6 months since prior chemotherapy

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

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thomas Decaens, MD

    Centre Hospitalier Universitaire Henri Mondor

    PRINCIPAL INVESTIGATOR

  • Christophe Duvoux

    Centre Hospitalier Universitaire Henri Mondor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 3, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Last Updated

March 4, 2014

Record last verified: 2010-03

Locations

FR(1)