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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00474994
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed connective tissue neoplasm, including any of the following neoplastic subtypes:
* Vascular connective tissue neoplasms
* Leiomyosarcoma
* Dermatofibrosarcoma protuberans
* Chordoma
* Desmoid tumors
* High-grade undifferentiated pleomorphic sarcoma (e.g., malignant fibrous histiocytoma \[including myxofibrosarcoma\])
* Carcinosarcomas (e.g., malignant mixed Müllerian tumors)
* Giant hemangiomata
* Kaposi sarcoma
* Metastatic, locally advanced, or locally recurrent disease
* Measurable disease
* Tumor lesions in a previously irradiated area may be considered measurable provided there is evidence of growth that cannot be attributed to necrosis or bleeding
* No gastrointestinal stromal tumor sarcomas
* Prior standard neoadjuvant or adjuvant systemic therapy required for patients with the following diagnoses:
* Rhabdomyosarcoma
* Osteosarcoma
* Ewing sarcoma
* No untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as documented on screening CT scan or MRI
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 mg/dL
* PT and INR ≤ 1.5
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL
* Calcium ≤ 12 mg/dL
* Blood glucose \< 150 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study therapy
* Other malignancies allowed provided sarcoma is the primary disease requiring systemic therapy
* Able to swallow oral medications
* No other disease or illness within the past 6 months, including any of the following:
* Myocardial infarction
* Severe or unstable angina
* Coronary or peripheral artery bypass graft
* Symptomatic congestive heart failure
* Cerebrovascular accident or transient ischemic attack
* Pulmonary embolism
* No evidence of a bleeding diathesis
* No ongoing cardiac dysrhythmias \> grade 2
* No uncontrolled hypertension, defined as blood pressure \> 150/100 mm Hg despite optimal medical therapy
* Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan
* No psychiatric illness or social situation that would preclude study compliance
* No pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication
* No prolonged QTc interval (i.e., QTc \> 450 msec for males or QTc \> 470 msec for females) on baseline EKG
* No hemorrhage ≥ grade 3 in the past 4 weeks
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* No prior sunitinib malate
* No more than 3 prior cytotoxic chemotherapy regimens for metastatic disease
* Adjuvant chemotherapy for sarcoma completed \> 1 year prior to study entry is not considered a line of prior treatment
* At least 2 weeks since prior cytotoxic chemotherapy
* At least 6 weeks since prior carmustine or mitomycin C
* At least 1 week since prior biological therapy or small molecule kinase inhibitors
* At least 3 weeks since prior radiotherapy (except for palliative radiotherapy to specific sites)
* Prior palliative radiotherapy allowed provided it is considered medically necessary and there are other target lesions to assess
* More than 4 weeks since prior major surgery
* Concurrent major surgery allowed provided study drug is stopped 2 weeks before surgery and resumed 2 weeks after surgery
* Concurrent palliative radiotherapy (e.g., focal radiotherapy to a bony metastasis for relieving bone pain) allowed
* No other concurrent investigational drugs
* No concurrent participation in another clinical trial
* No concurrent therapeutic anticoagulation (e.g., warfarin)
* Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices allowed provided requirements for PT and INR are met
* No other concurrent approved or investigational anticancer agents or treatment, including chemotherapy, biological response modifier therapy, hormonal therapy, or immunotherapy
* Concurrent hormone replacement therapy for adrenal insufficiency allowed
* No concurrent antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
* No concurrent rifampin, theophylline, ketoconazole, or Hypericum perforatum (St. John's wort)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00474994
Study Brief:
Protocol Section:
NCT00474994