Status:
UNKNOWN
Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 we...
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 * Det...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00874874
Start Date
May 1 2008
Last Update
December 24 2009
Active Locations (1)
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1
Centre Oscar Lambret
Lille, France, 59020