Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas (NCT00474994) | Clinical Trial Compass
CompletedPhase 2
Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas
United States53 participantsStarted 2007-04
Plain-language summary
RATIONALE: Sunitinib 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 sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent sarcomas.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …