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Palbociclib + Chemoradiation for Head and Neck Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT03007979Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Cohort 1: 1: palbociclib, 2: Cisplatin & IMRT, 3: palbociclib
- Group 2: Cohort 2: 1: palbociclib, 2: Cetuximab & IMRT, 3: palbociclib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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)."
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