Palbociclib + Chemoradiation for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDouglas R. Adkins

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient characteristics), followed by adjuvant single-agent palbociclib.

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

-- Bilirubin 1.5-2 x IULN

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

+20 more

Exclusion 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.

+13 more

Participant Groups

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.

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