Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma … (NCT03524326) | Clinical Trial Compass
CompletedPhase 1
Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma
United States24 participantsStarted 2018-04-30
Plain-language summary
This is a phase I study, which tests the safety of different doses of lenvatinib in combination with cetuximab, to see which dose is the safest in people. This study will help find out if lenvatinib and cetuximab is a safe and useful combination for treating patients with HNSCC and cSCC.
Who can participate
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:
* Histological or cytologic diagnosis of squamous cell cancer
* Clinical diagnosis of squamous cell cancer of the head and neck (non-nasopharynx primary tumors: oral cavity, oropharynx, hypopharynx, larynx and sinonasal) or skin
* HNSCC and cSCC cannot be curable by surgery and/or radiation therapy
* Measureable disease as per RECIST v1.1, which includes locoregional lesions (not amenable to curative surgery and/or radiation) and distant metastatic lesions
* Blood pressure \< 150/90 at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to initiation of treatment
* ECOG Performance Status of 0-1
* Adequate renal function as evidenced by calculated creatinine clearance \> 30 ml/min according to the Cockcroft and Gault Formula or by 24 hour urine creatinine clearance
* Adequate liver function as determined by (1) Bilirubin \< 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert"s syndrome; (2) ALT and AST \< 3 x ULN (\<5 x ULN if subject has liver mets)
* Adequate hematologic function as determined by (1) platelets \> 100,000; (2) Hemoglobin \> 9 gm/dl; (3) absolute neutrophil count \> 1200
* Adequate archival tissue to perform molecular analysis through MSK-IMPACT if MSK-IMPACT has not been performed previously on the patient"s tumor; if MSK-IMACT has not been previously performed and adequate archival tissue is not available, a patient should be agreeab…
What they're measuring
1
Maximum tolerated dose of Lenvatinib when combined with Cetuximab