Study on Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) for Patients with Incurable Head and Neck Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT02270814

Provider View

This clinical trial is exploring a new treatment combination called CACTUX for patients with incurable head and neck cancer. The treatment includes three drugs: cisplatin, nab-paclitaxel, and cetuximab. Researchers are studying how well this combination works and what side effects it may cause.

Patient Parameters

Program Overview

The aim of this study is to test a new treatment combination called CACTUX for head and neck cancer that cannot be cured. CACTUX includes three drugs: cisplatin, nab-paclitaxel, and cetuximab. If patients have had issues with cisplatin before, carboplatin may be used instead. This study is different because nab-paclitaxel is used instead of a drug called 5FU, which is usually part of the standard treatment. Researchers want to see how patients respond to this treatment and what side effects they might experience.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with incurable head and neck squamous cell carcinoma (HNSCC) in specific areas like the mouth, throat, or voice box, or with certain neck lymph node cancers.
  • Cancer must be measurable by scans or physical exams.
  • Must be 18 years or older.
  • Must be in good general health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate blood cell counts and organ function, including:
    • White blood cells of at least 3,000/mcL.
    • Neutrophil count of at least 1,500/mcL.
    • Platelet count of at least 100,000/mcL.
    • Total bilirubin level of 1.5 mg/dL or lower.
    • Liver enzymes within specified limits unless bone metastasis is present without liver metastasis.
    • Normal kidney function or creatinine clearance of at least 60 mL/min/1.73 m2.
  • At least 4 months since completing any previous curative treatment.
  • Must provide a tumor tissue sample for research purposes.
  • Women and men must agree to use effective birth control during the study and for 3 months after treatment.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have received prior treatment for incurable cancer.
  • Have moderate to severe nerve damage (peripheral neuropathy).
  • Have had another cancer within the past 2 years, except for certain low-risk cancers.
  • Currently taking other experimental drugs.
  • Have known brain metastases.
  • Have a history of severe allergic reactions to similar drugs used in the study, except for mild reactions to cetuximab.
  • Have uncontrolled health issues like infections, heart failure, or psychiatric conditions that could interfere with the study.
  • Are pregnant or breastfeeding, or have a positive pregnancy test before starting treatment.
  • Are HIV-positive and on antiretroviral therapy due to potential drug interactions and increased risk of infections.

Locations

FACILITYZIPCITYSTATE
University of Arkansas for Medical Sciences72205Little RockArkansas
University of Mississippi Medical Center39216JacksonMississippi
Washington University School of Medicine63110St LouisMissouri
Sanford Roger Maris Cancer Center58122FargoNorth Dakota
Sanford Cancer Center Oncology Clinic and Pharmacy57104Sioux FallsSouth Dakota

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