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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
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 belowSelect...
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.
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
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 moreSide effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Sinusitis
17%
Peripheral sensory neuropathy
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Hypophosphatemia
9%
Epistaxis
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Death
6%
Cataract
6%
Dehydration
6%
Knee pain
6%
Itchy skin
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Back spasms
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Burn
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Sinus pain
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Intrascapular pain
2%
Hemorrhoids
2%
Pharyngitis
2%
Activated partial thromboplastin time prolonged
2%
Erythema right breast
2%
Sinus tachycardia
2%
Puncture wound
2%
Hypermagnesemia
2%
Vaginal discharge
2%
Leg pain
2%
Wrist fracture
2%
Erythema multiforme
2%
Cold sweats
2%
Paronychia
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Facial nerve disorder
2%
Paresthesia
2%
Urinary retention
2%
Hyperuricemia
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
COPD
2%
Fracture
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
2%
Lung cancer
2%
Vaginal itching
2%
Radiation recall reaction (dermatologic)
2%
Bilateral nares sores
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
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%
Blister
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
~3760
Peripheral blood draw
2017
Completed Phase 2
~80
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
1,940 Previous Clinical Trials
2,303,369 Total Patients Enrolled
PfizerIndustry Sponsor
4,575 Previous Clinical Trials
10,923,075 Total Patients Enrolled
Douglas R Adkins, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
308 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.I am not taking any proton pump inhibitors.I do not have any serious illnesses that are not under control.I can walk and take care of myself, but I cannot do any work.My cancer is in the larynx, hypopharynx, or oral cavity and is not related to HPV.I have had cancer other than skin, prostate, thyroid, or cervical cancer in the last 2 years.I have skin, sinus, salivary gland, throat cancer, or cancer in neck nodes with an unknown primary source.I am not taking any strong medication that affects liver enzymes.I am not taking medication that affects my heart's rhythm.I am not pregnant or breastfeeding and agree to use effective birth control during and after the trial.My cancer can be measured by scans or physical exam.My organs are working well.My kidney function tests are within normal limits.My organs are not working as well as they should.My kidney function, measured by creatinine clearance, is between 30-75 mL/min.My bone marrow is functioning normally.You are currently taking experimental medications that are still being tested.I am HIV-positive and on antiretroviral therapy.My throat cancer is HPV-related.I haven't had any treatments in the week before starting the study's treatment.I have received systemic therapy for my current head and neck cancer diagnosis.I have a history of cirrhosis.I am 18 years old or older.I am fully active or can carry out light work.I am allergic to medications similar to palbociclib, cisplatin, or cetuximab.I have had a kidney or liver transplant.My cancer is at stage III, IVA, or IVB.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: 1: palbociclib, 2: Cisplatin & IMRT, 3: palbociclib
- Group 2: Cohort 2: 1: palbociclib, 2: Cetuximab & IMRT, 3: palbociclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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