Cabozantinib in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03667482
Phase
PHASE1
Status
Completed

Conditions

  • Head and Neck Squamous Cell Cancer
  • Metastatic Head and Neck Squamous Cell Cancer
  • Recurrent Head and Neck Squamous Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.
  • Cetuximab — DRUG
    Cetuximab will be administered at 500 mg/m\^2 intravenously every other week on Days 1 and 15 of each cycle, with a window of up to 3 days before the scheduled date. In an effort to prevent a hypersensitivity reaction, it is recommended that all patients pre-medications, hydration, and anti-emetics will be given according to institutional guidelines and/or per treating physician discretion.

Study Details

The purpose of this study is to test the safety of cabozantinib, at different doses, in combination with cetuximab to find out what effects, if any, this combined treatment has on people with HNSCC.

Key Dates

Start date
Sep 7, 2018
Status verified
Jul 2024
Primary completion
Jul 17, 2024
Completion
Jul 17, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib in Combination With Cetuximab
    Cetuximab will be administered at 500 mg/m\^2 intravenously every other week. Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.

Primary Outcome Measure

maximum tolerated dose (MTD) [ Time Frame: 2 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Baptist Alliance MCIMiamiFlorida33143-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-
Lehigh Valley Health NetworkAllentownPennsylvania18103-

Find similar trials in Miami, FL

By research site
Baptist Alliance MCI· Miami, FLMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NY

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