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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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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



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


- 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

- 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.

Inclusion Criteria


- 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)


- 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

- 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


- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Rate of non-progression at 9 months by RECIST criteria

Safety Issue:


Principal Investigator

Nicolas Penel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret



Study ID:




Start Date:

May 2008

Completion Date:

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • adult angiosarcoma
  • Hemangiosarcoma
  • Sarcoma