Testing Docetaxel-Cetuximab or Adding Atezolizumab to Usual Chemotherapy and Radiation in High-Risk Head and Neck Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01810913

Provider View

This clinical trial is exploring whether adding different drugs to the usual chemotherapy and radiation treatment can improve outcomes for patients with high-risk head and neck cancer. The study compares the standard treatment with new combinations, including the addition of an immunotherapy drug, atezolizumab.

Patient Parameters

Program Overview

This study is investigating how well radiation therapy works when combined with chemotherapy drugs like cisplatin, docetaxel, and cetuximab, and possibly adding an immunotherapy drug called atezolizumab. The goal is to see if these combinations can better control high-risk stage III-IV head and neck cancer that starts in squamous cells. The study will compare the usual treatment (radiation with cisplatin) to new combinations, including docetaxel and cetuximab, and the usual treatment with atezolizumab.

Description

The study has several main goals:

  • To find out if adding docetaxel and cetuximab to radiation therapy improves survival without the cancer returning, compared to the standard treatment with cisplatin and radiation. (Phase II)
  • To see if the combination of docetaxel-cetuximab and radiation is better for overall survival than the standard treatment in patients with high-risk, HPV-negative head and neck cancer. (Phase III)
  • To determine if adding atezolizumab to cisplatin and radiation improves overall survival compared to the standard treatment. (Phase III)

Secondary goals include comparing how well each treatment controls the cancer locally and prevents it from spreading, as well as comparing side effects and quality of life between the different treatment groups.

The study involves different treatment groups:

  • Group 1: Patients receive radiation therapy and cisplatin chemotherapy.
  • Group 2: (Closed) Patients receive radiation therapy and docetaxel chemotherapy.
  • Group 3: Patients receive cetuximab and docetaxel with radiation therapy.
  • Group 4: Patients receive radiation therapy, cisplatin, and atezolizumab.

Patients will have regular scans and blood tests during follow-up to monitor their health and the cancer's response to treatment. Follow-up visits will occur at 1 and 3 months, then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk head and neck squamous cell carcinoma (HNSCC) in specific areas like the oral cavity, oropharynx (p16 negative), larynx, or hypopharynx.
  • Must have had surgery to remove the cancer within 63 days before joining the study.
  • Must have certain high-risk features like cancer spread beyond lymph nodes or cancer at the edge of the removed tumor.
  • Must be stage III or IV without distant spread, based on specific medical exams and imaging.
  • Must be in good health with a performance status of 0-1.
  • Must be 18 years or older.
  • Must have adequate blood counts and organ function based on lab tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Must agree to provide tissue samples for research purposes.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Have had another invasive cancer within the last 3 years, except for certain skin cancers.
  • Have multiple primary cancers or tumors on both sides, except for specific cases.
  • Have had prior chemotherapy or radiation that overlaps with the study treatment area.
  • Have severe, active health conditions like heart failure, recent heart attack, or severe infections.
  • Have certain electrolyte imbalances that cannot be corrected.
  • Are pregnant or breastfeeding, or not willing to use contraception.
  • Have a history of severe allergic reactions to study drugs.
  • Have active infections like hepatitis or tuberculosis.
  • Have had a major surgery within 28 days before joining the study.
  • Have received a live vaccine within 4 weeks before joining the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.