Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery

December 23, 2009 updated by: Centre Oscar Lambret

Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the rate of non-progression at 9 months in patients with unresectable, locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate.

Secondary

  • Determine the rate of non-progression at 60, 120, and 180 days.
  • Determine the median time to progression.
  • Determine overall survival.
  • Determine the best response rate.
  • Determine the clinical and biological factors that predict clinical benefit.
  • Evaluate tolerability by NCI CTCAE v3.0.
  • Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis.
  • Explore the tumor expression of these genes in tissue from a tumor bank.

OUTLINE: This is a multicenter study.

Patients are stratified according to disease type (cutaneous angiosarcoma [scalp, breast, or soft tissue] vs visceral angiosarcoma). All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Nicolas Penel, MD
          • Phone Number: 33-3-20-295-920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed angiosarcoma

    • Locally advanced or metastatic disease
    • Unresectable disease
  • No Kaposi sarcoma, hemangiopericytoma, or hemangioendothelioma
  • Measurable tumor with at least 1 measurable lesion by RECIST criteria
  • Tumor in a previously irradiated area must not show progression
  • No brain metastases or meningeal tumors (symptomatic or asymptomatic)

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL

  • PT or INR and aPTT ≤ 1.5 times upper limit of normal (ULN)

    • Anticoagulation treatment with heparin or vitamin K allowed if the above criteria are met
  • Liver transaminases ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
  • Total bilirubin ≤ 1.5 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Amylase and lipase ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Weight loss from pre-disease weight < 20% over the past 12 months
  • Able to swallow
  • No active or ischemic coronary artery disease
  • No myocardial infarction within the past 6 months
  • No NYHA class III-IV cardiac failure
  • No uncontrolled hypertension
  • No coagulopathy
  • No active uncontrolled peptic ulcer
  • No patients on renal dialysis
  • No active bacterial or fungal infection > CTCAE v3.0 grade 2
  • No HIV or hepatitis B or C positivity
  • No chronic unstable illness that could jeopardize patient safety or compliance
  • No other progressive or malignant tumor
  • No known or suspected allergy to sorafenib tosylate
  • No psychological, familial, social, or geographic situations that preclude clinical follow up
  • No patients deprived of liberty or under guardianship
  • No cardiac arrhythmia requiring antiarrhythmic medication (except beta-blockers or digoxin for chronic atrial fibrillation)
  • No epilepsy requiring antiepileptic drugs

PRIOR CONCURRENT THERAPY:

  • See Patient Characteristics
  • No prior organ or peripheral stem cell transplantation
  • No more than 2 prior lines of chemotherapy
  • At least 28 days since prior treatment (systemic or major surgery)
  • No concurrent therapy for another malignancy
  • No concurrent CYP3A inducers (e.g., rifampicin, St. John wort, phenytoin, carbamazepine, phenobarbital, dexamethasone)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of non-progression at 9 months by RECIST criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (ESTIMATE)

April 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000633547
  • COL-Angio-Next
  • BAYER-COL-Angio-Next
  • COL-2007-10
  • INCA-RECF0636
  • EUDRACT-2007-004651-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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