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Monoclonal Antibodies

PD 0332991 + Cetuximab for Squamous Cell Carcinoma

Phase 1 & 2

Waitlist Available

Led By Douglas 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what dose is safe and what side effects it causes when combined with another cancer drug.

Who is the study for?

This trial is for adults with incurable squamous cell carcinoma of the head and neck (SCCHN), who have tried at least one treatment cycle without success. Participants must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and cannot have certain health conditions like uncontrolled heart disease or active infections.Check my eligibility

What is being tested?

The study is testing the combination of a drug called PD 0332991 with cetuximab to find the highest dose patients can tolerate without severe side effects. It's in Phase I/II which means they're looking at safety and how well it works on different groups based on prior treatments and HPV-related cancer status.See study design

What are the potential side effects?

Possible side effects include allergic reactions similar to those from compounds related to PD 0332991 or cetuximab, as well as general risks associated with cancer drugs such as fatigue, digestive issues, skin reactions, blood disorders, and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I - Maximum Tolerated Dose (MTD)

Phase II: Efficacy as Measured by Overall Response Rate

Secondary outcome measures

Phase I: Most Frequent Adverse Events

Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events

Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events

+4 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase II Arm 3:Experimental Treatment2 Interventions

PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle. Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.

Group II: Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHNExperimental Treatment2 Interventions

Group III: Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHNExperimental Treatment2 Interventions

Group IV: Phase I: Dose Level 2Experimental Treatment2 Interventions

Group V: Phase I: Dose Level 1Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

PD 0332991

2008

Completed Phase 2

~360

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,778 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,613 Total Patients Enrolled

Douglas Adkins, M.D.Principal InvestigatorWashington University School of Medicine

11 Previous Clinical Trials

467 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02101034 — Phase 1 & 2

Squamous Cell Carcinoma Research Study Groups: Phase I: Dose Level 2, Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN, Phase I: Dose Level 1, Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN, Phase II Arm 3:

Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT02101034 — Phase 1 & 2

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02101034 — Phase 1 & 2

Frequently Asked Questions

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

What therapeutic results are investigators hoping to achieve through this clinical trial?

"This trial, which is expected to culminate in Phase I results after 6 months of observation, aims to measure efficacy by Overall Response Rate. Additionally, NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used as a metric in order to gauge the frequency and intensity of PD 0332991 related adverse events occurring on 10% or more participants at any point throughout the study; cetuximab-related adverse events with similar criteria are also observed during Phase II."

Answered by AI

Are there any established precedents for Cetuximab trials?

"Since 2007 when the first trial of cetuximab was conducted at Saint Bartholomew's Hospital, 445 studies have been completed. Currently there are 248 active trials worldwide; many located in and around Missouri's largest city - St Louis."

Answered by AI

Is it possible for participants to still join this experiment?

"The clinicaltrials.gov information attests that this study is not currently recruiting patients, having been initially posted on June 17th 2014 and last edited on November 1st 2022. At the moment, however, there are 1018 other medical trials which require enrolment of volunteers."

Answered by AI

How extensive is the enrollment for this clinical trial?

"Unfortunately, recruitment for this investigation has been paused. Originally posted on June 17th 2014 and most recently modified November 1st 2022, the study is currently not searching for participants. However, those interested in other clinical trials can view 770 studies actively admitting patients with carcinoma, squamous cell and 248 research initiatives utilizing Cetuximab that are still accepting recruits."

Answered by AI

Which medical conditions are typically treated with Cetuximab?

"Cetuximab can be used to treat radiation therapy, metastatic squamous cell carcinoma of the head and neck (hnscc), as well as other forms of squamous cell carcinoma."

Answered by AI

What is the overall number of healthcare centers currently administering this experiment?

"This clinical trial is enlisting patients from Washington University School of Medicine in Saint Louis, Winship Cancer Institute at Emory University located in Atlanta and the University of Michigan Health System based in Ann Arbor. Additionally, there are 5 other locations involved with this study."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Palbociclib and Cetuximab in Platinum-resistant and in Cetuximab-resistant Human Papillomavirus-unrelated Head and Neck Cancer: A Multicentre, Multigroup, Phase 2 Trial

Adkins, Douglas, Jessica Ley, Prakash Neupane, Francis Worden, Assuntina G Sacco, Kevin Palka, Juneko E Grilley-Olson, et al.. 2019. “Palbociclib and Cetuximab in Platinum-resistant and in Cetuximab-resistant Human Papillomavirus-unrelated Head and Neck Cancer: A Multicentre, Multigroup, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30405-x.

clinicaltrials.govStudy

PD 0332991 and Cetuximab in Patients With Incurable SCCHN

2014. "PD 0332991 and Cetuximab in Patients With Incurable SCCHN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02101034.