Cabozantinib S-malate in Treating Patients With Metastatic Pheochromocytomas or Paragangliomas Th… (NCT02302833) | Clinical Trial Compass
CompletedPhase 2
Cabozantinib S-malate in Treating Patients With Metastatic Pheochromocytomas or Paragangliomas That Cannot Be Removed by Surgery
United States21 participantsStarted 2015-02-17
Plain-language summary
This pilot phase II trial studies how well cabozantinib s-malate works in treating patients with pheochromocytomas or paragangliomas that have spread from the primary site to other places in the body and cannot be removed by surgery. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histological confirmation of pheochromocytoma (PH)/paraganglioma (PG)
* Locally advanced or metastatic disease not amenable to surgery
* Patients enrolled in the main branch should have measurable disease; patients with a predominance of bone disease who have small, non-measurable or small measurable lesions other than bone, may be included per the principal investigator's discretion, in the exploratory branch of the study for patients with bone metastases only
* Progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the investigator within the 12 months preceding study enrollment
* Assessment of all known disease sites, e.g., by CT scan, MRI, bone scan as appropriate, and/or FDG-PET scan within 28 days before the first dose of cabozantinib
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Life expectancy of at least 3 months
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 without colony stimulating factor support (within 4 days prior to the first dose of cabozantinib)
* Platelets \>= 100,000/mm\^3 (within 4 days prior to the first dose of cabozantinib)
* Hemoglobin \>= 9 g/dL (within 4 days prior to the first dose of cabozantinib)
* Bilirubin =\< 1.5 x the upper limit of normal (ULN) (for subjects with known Gilbert's disease, bilirubin =\< 3.0 mg/dL) (within 4 days prior to the first dose of cabozantinib)
* Serum albumin \>= 2.8 g/dl (within 4 days prior to the first dose of cabozantini…