Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable … (NCT00874874) | Clinical Trial Compass
UnknownPhase 2
Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery
France96 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 oth…
What they're measuring
1
Rate of non-progression at 9 months by RECIST criteria