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Palbociclib + Chemoradiation for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Douglas R Adkins, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

- ECOG performance status of 2

-- Serum creatinine ≤ 1.5 x institutional upper limit of normal (IULN) and creatinine clearance ≥ 75 mL/min

Must not have

Presence of distant metastatic disease.

- Drugs that are proton pump inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 18 months after completion of step 2

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that involves taking a drug called palbociclib before and after chemoradiation, to see if it improves outcomes for people with HPV-unrelated head and neck squamous cell carcinoma.

Who is the study for?

Adults with stage III/IV HPV-unrelated head and neck squamous cell carcinoma, who have not received prior systemic therapy for it. They must have measurable disease, normal bone marrow function, adequate organ function, and agree to use contraception. Excluded are those with distant metastasis, certain drug interactions or allergies, pregnant/breastfeeding women, HIV-positive on antiretroviral therapy, other recent malignancies (except some skin/prostate/thyroid/cervical cancers), or uncontrolled illnesses.

What is being tested?

The trial tests the effectiveness of palbociclib monotherapy before and after chemoradiation therapy in patients with specific head and neck cancer. Chemoradiation involves cisplatin plus IMRT or cetuximab plus IMRT based on patient characteristics. The study aims to see how well patients respond to this treatment sequence.

What are the potential side effects?

Palbociclib may cause low blood counts leading to increased infection risk or bleeding problems; fatigue; nausea; hair thinning; rash. Cisplatin can lead to kidney damage, hearing loss, nerve issues while cetuximab might cause an acne-like rash or infusion reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can walk and take care of myself, but I cannot do any work.

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My kidney function tests are within normal limits.

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My kidney function, measured by creatinine clearance, is between 30-75 mL/min.

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My bone marrow is functioning normally.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer is at stage III, IVA, or IVB.

Exclusion Criteria

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

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My cancer has spread to distant parts of my body.

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I am not taking any proton pump inhibitors.

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I do not have any serious illnesses that are not under control.

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I have skin, sinus, salivary gland, throat cancer, or cancer in neck nodes with an unknown primary source.

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I am not taking any strong medication that affects liver enzymes.

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I am not taking medication that affects my heart's rhythm.

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I am HIV-positive and on antiretroviral therapy.

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My throat cancer is HPV-related.

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I haven't had any treatments in the week before starting the study's treatment.

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I have received systemic therapy for my current head and neck cancer diagnosis.

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I have a history of cirrhosis.

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I am allergic to medications similar to palbociclib, cisplatin, or cetuximab.

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I have had a kidney or liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 18 months after completion of step 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 18 months after completion of step 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 18 months after completion of step 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Tumor Response Rate of Newly Diagnosed p16INK4a Negative, HPV-unrelated HNSCC to Neoadjuvant Palbociclib Monotherapy

Secondary study objectives

Association Between Baseline Tumor CDKN2A and CCND1 Alterations and Tumor Response to Palbociclib Given Before CRT and Relapse After CRT

Change in Genomic Alterations in Tumor Tissue

Combined Local-regional Disease Relapse Risk and Distant Metastases Risk Following Completion of CRT

+4 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Headache

17%

Mucositis

17%

Diarrhea

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Obesity

10%

Flu like symptoms

Pain in extremity

Constipation

Fever

Dizziness

Dyspepsia

Hot flashes

Bone pain

Pruritus

Pain

Dysgeusia

Abdominal pain

Respiratory infection

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Dislocation of hip

Renal failure

Bronchial infection

Urinary tract infection

Thromboembolic event

Palmar-plantar erythrodysesthesia syndrome

Osteonecrosis of jaw

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: 1: palbociclib, 2: Cetuximab & IMRT, 3: palbociclibExperimental Treatment5 Interventions

* Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT

Group II: Cohort 1: 1: palbociclib, 2: Cisplatin & IMRT, 3: palbociclibExperimental Treatment5 Interventions

* Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3790

Peripheral blood draw

2017

Completed Phase 2

~130