Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00217620
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma of 1 of the following histologies:
* Angiosarcoma, cutaneous or visceral
* Malignant hemangiosarcoma
* Malignant hemangiopericytoma
* Grade 3-4 leiomyosarcoma
* Grade 3-4 liposarcoma
* Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography
* Measurable disease by x-ray, scans, or physical examination
* Archived paraffin-embedded tumor sections available
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
* Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)
* PT, PTT, and INR normal
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No history of thromboembolic disease
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to swallow oral medication
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered
* Prior adjuvant chemotherapy allowed
* No more than 1 prior chemotherapy regimen for metastatic disease
Endocrine therapy
* Not specified
Radiotherapy
* At least 28 days since prior radiotherapy and recovered
* Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy
Surgery
* At least 28 days since prior major surgery and recovered
Other
* No prior sorafenib
* No prior inhibitor of VEGFR or MAPK pathway
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No concurrent therapeutic anticoagulation
* No concurrent administration of any of the following medications:
* Rifampin
* Hypericum perforatum (St. John's wort)
* Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
* Phenytoin
* Carbamazepine
* Phenobarbital
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00217620
Study Brief:
Protocol Section:
NCT00217620