Phase 2
N=3
Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery
Malignant Adrenal Gland Pheochromocytoma · Malignant Paraganglioma · Metastatic Adrenal Gland Pheochromocytoma
Bottom Line
View on ClinicalTrials.gov: NCT03008369 ↗Enrolled (actual)
3
Serious AEs
33.3%
Results posted
May 2021
Primary outcome: Primary: Confirmed Tumor Response Rate — 1.0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Lenvatinib (Drug); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Tumor Response Rate |
1.0 | — |
| SECONDARY Duration of Tumor Response |
9.7 | — |
| SECONDARY Patients Evaluable for Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0 |
3 | — |
| SECONDARY Overall Survival Time |
NA | — |
| SECONDARY Progression-free Survival |
11.5 | — |
| SECONDARY Quality of Life Assessed by EQ-5D and FACT-G |
— | — |
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.
Eligibility Criteria
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 = = 500 msecs)
- Left ventricular ejection fraction (LVEF) 84 days) is allowed
- Serious or non-healing wound, ulcer, or bone fracture
- History of familial QTc prolongation syndrome
- Any of the following conditions =< 6 months prior to registration:
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Serious or unstable cardiac arrhythmia
- Admission for unstable angina or myocardial infarction
- Cardiac angioplasty or stenting
- Coronary artery bypass graft surgery
- Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation =< 30 days
- Arterial thrombosis
- Symptomatic peripheral vascular disease
- Other active malignancy =< 2 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer; NOTE: adjuvant anti-estrogen/hormonal therapy for breast cancer is allowed
Data sourced from ClinicalTrials.gov (NCT03008369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.