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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
Larynx SCC, hypopharynx SCC, or oral cavity SCC. HPV-unrelated OPSCC [defined as p16INK4a negative by IHC (staining in < 70% of cells) or HPV High Risk (Type 16 or 18) negative by ISH]. P16INK4a positive larynx SCC, hypopharynx SCC, and oral cavity SCC are eligible given the unknown effect of this on the biology of SCC of these subsites.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 18 months after completion of step 2
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 cancer is in the larynx, hypopharynx, or oral cavity and is not related to HPV.
Select...
My cancer can be measured by scans or physical exam.
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My organs are working well.
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My kidney function tests are within normal limits.
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My organs are not working as well as they should.
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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.
Select...
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor Response Rate of Newly Diagnosed p16INK4a Negative, HPV-unrelated HNSCC to Neoadjuvant Palbociclib Monotherapy
Secondary outcome measures
Combined Local-regional Disease Relapse Risk and Distant Metastases Risk Following Completion of CRT
Median Overall Survival (OS) of Patients Treated With the Three Step Sequence of Palbociclib Monotherapy, CRT, and Adjuvant Palbociclib Monotherapy
Median Progression-free Survival (PFS) (Stratified by Cohort) of Patients Treated With the Three Step Sequence of Palbociclib Monotherapy, CRT, and Adjuvant Palbociclib Monotherapy
+2 more

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979
91%
White blood cell count decreased
87%
Neutrophil count decreased
87%
Hypertension
83%
Fatigue
76%
Anemia
72%
Lymphocyte count decreased
57%
Nausea
54%
Back pain
52%
Diarrhea
52%
Hot flashes
44%
Headache
44%
Arthralgia
43%
Cough
43%
Alopecia
41%
Anorexia
41%
Dizziness
39%
Insomnia
35%
Hypercalcemia
35%
Pain
33%
Creatinine increased
33%
Platelet count decreased
31%
Dyspnea
31%
Edema limbs
31%
Hyponatremia
31%
Constipation
30%
Hyperkalemia
30%
Aspartate aminotransferase increased
28%
Peripheral sensory neuropathy
28%
Alkaline phosphatase increased
28%
Vomiting
28%
Alanine aminotransferase increased
28%
Hypocalcemia
28%
Depression
26%
Mucositis oral
26%
Anxiety
24%
Dyspepsia
22%
Chills
22%
Rash maculopapular
20%
Dysgeusia
20%
Hyperglycemia
19%
Sinusitis
19%
Dry skin
17%
Allergic rhinitis
17%
Hypokalemia
17%
Sore throat
17%
Myalgia
17%
Fall
15%
Hypoalbuminemia
15%
Upper respiratory infection
13%
Fever
13%
Hyperhidrosis
11%
Epistaxis
11%
Urinary tract infection
11%
Breast pain
11%
Bone pain
11%
Arthritis
11%
Lymphedema
9%
Skin infection
9%
Knee pain
9%
Hypernatremia
9%
Pain in extremity
9%
Pleural effusion
9%
Nasal congestion
9%
Dysphagia
9%
Gastroesophageal reflux disease
7%
Hypophosphatemia
7%
Itchy skin
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Thromboembolic event
6%
Blurred vision
6%
Respiratory syncytial virus (RSV)
6%
Vertigo
6%
Red eye
6%
Non-cardiac chest pain
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Bronchitis
6%
Lung infection
6%
Sacroliac joint pain
6%
Shoulder pain
6%
Osteopenia
6%
Rash acneiform
6%
Leg stiffness
6%
Gout
6%
Weight loss
6%
Blister
4%
Dry eye
4%
Right arm numbness
4%
Nodule
4%
Watering eyes
4%
Edema trunk
4%
Flu-like symptoms
4%
Vaginal dryness
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Sinus pain
4%
Hemoglobin increased
4%
Dry mouth
4%
Tick bite
4%
Allergic reaction
4%
Extremity infection
4%
Hypoglycemia
4%
Generalized muscle weakness
4%
Sleep apnea
4%
Right thumb bump
4%
Urinary frequency
4%
Chest pain - cardiac
4%
Muscle cramp
4%
Muscle spasm
4%
Bruising
4%
Bug bite
4%
Burn - left hand
4%
Brittle nail
2%
Gait disturbance
2%
Peeling lips
2%
Cataract
2%
Paresthesia
2%
Vaginal itch
2%
Photophobia
2%
Facial nerve disorder
2%
Erythema right breast
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Radiation recall reaction (dermatologic)
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Erythema multiforme
2%
Peeling skin palms of hands
2%
Urinary retention
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Tooth infection
2%
Laryngeal inflammation
2%
Activated partial thromboplastin time prolonged
2%
Abdominal pain
2%
Fracture
2%
Urine discoloration
2%
Asthma
2%
Hoarseness
2%
Wrist fracture
2%
Hand cramps
2%
C. difficile
2%
Hemorrhoids
2%
Pharyngitis
2%
Left hand puncture wound
2%
Vaginal discharge
2%
Nail loss
2%
Oral fissure
2%
Superficial thrombophlebitis
2%
Dry lips
2%
Paronychia - infection right middle
2%
Snake bite
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Toothache
2%
Ulcerative colitis
2%
Acute bronchitis
2%
COVID-19
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Hypomagnesemia
2%
Bilateral leg pain
2%
Chest wall pain
2%
Flank pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Rhinovirus
2%
Voice alteration
2%
Cellulitis
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Osteonecrosis of jaw
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Acute kidney injury
2%
Asystole
2%
Generalized weakness
2%
Sepsis
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Eye lid pain
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant

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
~3720
Peripheral blood draw
2017
Completed Phase 2
~60
Cisplatin
2013
Completed Phase 3
~1940
Cetuximab
2011
Completed Phase 3
~2480
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Tumor biopsy
2014
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,062 Total Patients Enrolled
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,657 Total Patients Enrolled
Douglas R Adkins, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
308 Total Patients Enrolled

Media Library

Palbociclib Clinical Trial Eligibility Overview. Trial Name: NCT03389477 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Cohort 1: 1: palbociclib, 2: Cisplatin & IMRT, 3: palbociclib, Cohort 2: 1: palbociclib, 2: Cetuximab & IMRT, 3: palbociclib
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT03389477 — Phase 2
Palbociclib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03389477 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants in this trial?

"This trial is currently not recruiting participants. The listing, first posted on April 27th 2018 and last updated September 28th 2022, has been suspended for the time being. However there are 2 676 other trials looking to enroll patients with malignant neoplasms as well 915 studies involving Palbociclib that have active recruitment drives going at present."

Answered by AI

Has Palbociclib been explored in other research initiatives?

"Presently, there are 915 active clinical trials for Palbociclib with 310 of those in their final stage. Most studies take place in Shanghai, but the drug also has a reach to 54555 locations worldwide."

Answered by AI

Are individuals presently able to enlist in this research endeavor?

"At this moment, enrollment for this clinical trial is suspended. It was initially posted on April 27 2018 and its last update happened on September 28 2022. In the case that you are interested in alternative studies, there are presently 2676 trials recruiting patients with malignant neoplasms and 915 involving Palbociclib actively seeking participants."

Answered by AI

Does Palbociclib come with any known risks or hazards?

"As this trial is only in Phase 2, meaning that there are safety data but no efficacy information available, the team at Power assessed its safety as a two."

Answered by AI

What maladies is Palbociclib most often used to treat?

"Palbociclib is frequently prescribed for breast cancer, however there are other applications such as radiation therapy, advanced testicular cancer, and metastatic squamous cell carcinoma of the head and neck (hnscc)."

Answered by AI
~4 spots leftby Mar 2025