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Monoclonal Antibodies

Chemotherapy Combinations for Head and Neck Cancer ((UPCI)13-056 Trial)

Phase 2
Recruiting
Led By Heath Skinner, MD
Research Sponsored by Christopher Wilke
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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing which chemotherapy combo is more effective for treating HNSCC, as well as the side effects of the combos.

Who is the study for?
This trial is for adults with advanced head and neck squamous cell carcinoma (HNSCC) without distant metastasis. They must have stage III, IVa or IVb disease, be untreated by surgery for their current diagnosis, and not have had chemotherapy or radiation for HNSCC before. Those with a second HNSCC more than 2 years apart treated only by surgery are eligible; however, those with simultaneous primaries or bilateral tumors (except certain cases) cannot join.
What is being tested?
The study compares the effectiveness of two chemotherapy combinations in treating locally advanced HNSCC: one group receives IMRT with cisplatin while the other gets IMRT combined with docetaxel and cetuximab. Participants will be sorted based on HPV status and ERCC-1 levels in their tumor to see which treatment works best relative to these factors.
What are the potential side effects?
Possible side effects include reactions related to radiation therapy such as skin irritation and fatigue, as well as chemotherapy-related issues like nausea, vomiting, hair loss, low blood counts leading to increased infection risk or bleeding problems.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time To Progression (TTP)
Secondary study objectives
2-year (Time to Progression) TTP
Disease Related Blame Scale (DBS)
FACT-H&N FACT - Head & Neck
+12 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Cisplatin-IMRTActive Control2 Interventions
Cisplatin 40 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)
Group II: Docetaxel-Cetuximab-IMRTActive Control3 Interventions
Docetaxel 15 mg/m2 weekly x 7; Cetuximab 400 mg/m2 load, one week prior to IMRT; Cetuximab 250 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)

Find a Location

Who is running the clinical trial?

Christopher WilkeLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Heath SkinnerLead Sponsor
3 Previous Clinical Trials
206 Total Patients Enrolled
Heath Skinner, MDPrincipal Investigator - University of Pittsburgh
Magee-Women's Hospital of UPMC, Radiologic Consultants Ltd, UPMC McKeesport, UPMC Passavant-McCandless, UPMC Presbyterian, UPMC Shadyside, UPMC St. Margaret
West Virginia University School Of Medicine (Medical School)
1 Previous Clinical Trials
16 Total Patients Enrolled
~43 spots leftby Dec 2030
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