Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma Tha… (NCT03008369) | Clinical Trial Compass
CompletedPhase 2
Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery
United States3 participantsStarted 2017-05-31
Plain-language summary
This phase II trial studies how well lenvatinib works in treating patients with pheochromocytoma or paraganglioma that has spread to other places in the body or cannot be removed by surgery. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 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.
Inclusion Criteria:
* Histologically or cytologically confirmed malignant secretory or non-secretory pheochromocytoma or paraganglioma that is unresectable and deemed inappropriate for alternative local regional therapeutic approaches
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Life expectancy \> 24 weeks
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* White blood cell (WBC) count \>= 3,000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 9.0 g/dL (5.6 mmol/L); NOTE: transfusions are not allowed =\< 7 days prior to registration
* Total bilirubin =\< 1.5 X upper limit of normal (ULN) (or total bilirubin =\< 3.0 X ULN with direct bilirubin =\< 1.5 X ULN in patients with well-documented Gilbert's Syndrome)
* Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 X ULN
* Creatinine =\< 1.5 x ULN
* Urine protein/creatinine ratio =\< 1 OR 24-hour urine protein \< 1.5 gram
* Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Blood pressure (BP) \< 150 mmHg (systolic) and \< 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is \< 150/90 mmHg; NOTE: all patients with secretory pheochromocytoma or paraganglioma are REQUIRED to: 1) be evaluated in consultation by a hypertension specialist with specific expe…