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

Centre Oscar Lambret

Status and phase: Unknown; Phase 2

Conditions: Sarcoma

Treatments: Drug: sorafenib tosylate

Study type: Interventional

Funder types: Other

Identifiers

NCT00874874

COL-Angio-Next

CDR0000633547

INCA-RECF0636

COL-2007-10

BAYER-COL-Angio-Next

EUDRACT-2007-004651-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)