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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00874874
• Other study ID #: CDR0000633547
• Secondary ID: COL-Angio-NextBA
• Status: Recruiting
• Phase: Phase 2
• First received: April 2, 2009
• Last updated: December 23, 2009
• Start date: May 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• sorafenib tosylate

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of non-progression at 9 months by RECIST criteria			No