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Monoclonal Antibodies

Chemotherapy + Radiation Therapy for Head and Neck Cancer

Phase 2 & 3

Recruiting

Led By Paul M Harari

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18

Zubrod performance status of 0-1 within 14 days prior to registration

Must not have

Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer

Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization to death due to any cause, assessed up to 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well radiation therapy works in combination with different drugs after surgery to treat patients with high-risk stage III-IV head and neck cancer.

Who is the study for?

This trial is for adults with high-risk head and neck cancer who've had surgery to remove it. They should have no other cancers for the past 3 years, not be pregnant, and agree to birth control if needed. Key eligibility includes recent imaging tests, certain blood levels within normal ranges, a specific type of tumor (HNSCC), and good physical condition.

What is being tested?

The study compares usual treatment (radiation plus cisplatin) with radiation combined with docetaxel and cetuximab chemotherapy or adding atezolizumab immunotherapy. It aims to see which method is more effective in stopping cancer growth after surgery.

What are the potential side effects?

Possible side effects include skin reactions from radiation, nausea from chemotherapy drugs like cisplatin and docetaxel, allergic reactions to cetuximab, fatigue from atezolizumab immunotherapy, as well as potential impacts on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been mostly active and able to carry out all pre-disease activities until two weeks ago.

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My kidney function tests are within normal limits.

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My cancer has spread beyond the lymph node capsule or was found at the edge of the removed tumor.

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My head or neck cancer is stage III or IV but hasn't spread far.

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My cancer is a type of squamous cell carcinoma located in my head or neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received chemotherapy or anti-EGF therapy for my cancer.

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I am not pregnant and willing to use contraception if of childbearing potential.

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I've had radiation in the same area where my current cancer is located.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization to death due to any cause, assessed up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization to death due to any cause, assessed up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to death due to any cause, assessed up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free survival (DFS) (Phase II)

Overall survival (OS) (Phase III)

Secondary study objectives

Diabetes Mellitus

Local-regional failure (LRF)

Patient-reported outcome, symptom burden

+2 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 4 (IMRT, cisplatin, atezolizumab)Experimental Treatment9 Interventions

Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.

Group II: Arm 3 (IMRT, docetaxel, cetuximab)Experimental Treatment9 Interventions

Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive concurrent docetaxel once weekly for 6 weeks. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.

Group III: Arm 2 (IMRT, docetaxel)Experimental Treatment7 Interventions

Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks. Patients undergo CT scans and/or MRI, and collection of blood during follow-up. (CLOSED AS OF 20-MAR-2020)

Group IV: Arm 1 (IMRT, cisplatin)Experimental Treatment8 Interventions

Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Patients undergo collection of blood samples during screening and throughout the study and may undergo CT scans and/or MRI and biopsy as clinically indicated on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Cisplatin

2013

Completed Phase 3

~3120