- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04278092
Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure
March 14, 2023 updated by: Thorsten Fuereder, Medical University of Vienna
Paclitaxel Plus Cetuximab for the Treatment of Recurrent and/or Metastatic Head and Neck Cancer After First-line Checkpoint Inhibitor Failure: A Multicenter, Single Arm Study
Immune checkpoint inhibitors (CPI) such as pembrolizumab or nivolumab have been recently approved for the treatment of recurrent/metastatic head and neck cancer (HNSCC).
However, only a minority of patients respond to therapy.
From the clinical point of view the optimal management of patients progressing on or after CPI therapy is still a challenge.
Retrospective analysis showed that HNSCC patients, who progressed on/after CPI, demonstrated an overall response rate (ORR) of up to 30% subsequent to chemotherapy +/- cetuximab treatment.
It is the aim of this study to evaluate if paclitaxel plus cetuximab after first line pembrolizumab failure is an effective salvage therapy in 50 R/M HNSCC patients.
The primary endpoint is ORR according to RECIST V 1.1.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Wagner
- Phone Number: 72750 +43140400
- Email: christina.wagner@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Thorsten Fuereder, MD
- Phone Number: +4314040072750
- Email: thorsten.fuereder@meduniwien.ac.at
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient has provided written informed consent prior to any study-related procedure.
- The patient is at least 18 years of age
- Histologically proven locally advanced unresectable, recurrent and/or metastatic squamous cell carcinoma of the oropharynx, hypopharynx, larynx or oral cavity not amenable for salvage surgery
- p16 status has to be determined for oropharyngeal carcinomas
- Documented progressive disease based on investigator assessment according to RECIST 1.1, following receipt of a pembrolizumab based regimen given as first line therapy for R/M SCCHN
- Measurable disease according to RECIST 1.1.
- The patient has a life expectancy of at least 3 months.
- Has a performance status of ≤ 2 on the ECOG Performance Scale
- Female patient of childbearing potential should have a negative urine or serum pregnancy prior to study . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study until 120 days after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy until 120 days after the last dose of study therapy.
- Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 14 days of treatment initiation.
Exclusion Criteria:
- Prior taxane therapy is not allowed except as part of induction therapy for locally advanced disease (completed at least 6 months before study entry)
- Prior cetuximab therapy is not allowed except as part of either induction therapy or in combination with radiotherapy treatment for locally advanced disease (completed at least 6 months before study entry)
- Patients with nasopharyngeal carcinomas or salivary glands cancers
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency including a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis A/B or Hepatitis C
- Has had prior pembrolizumab within 2 weeks prior to study day 1 or who has not recovered (i.e., recovery to ≤ Grade 1 or baseline grade prior to pembrolizumab) from (immune- related) adverse events other than endocrine side effects.
- Has had prior chemotherapy or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., recovery to ≤ Grade 1 or baseline grade prior to pembrolizumab) from adverse events due to a previously administered agent.
- Has had chemotherapy, targeted therapy or investigational drugs after checkpoint inhibitor failure for second line therapy .
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit until 120 days after the last dose of trial treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paclitaxel plus Cetuximab
Paclitaxel combination with weekly cetuximab will be administered for up to six cycles.
Thereafter weekly cetuximab maintenance will be given.
|
Paclitaxel 175 mg/m2, q21
Other Names:
Cetuximab 400mg/m2 loading dose followed by weekly 250mg/m2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: 3 months
|
To evaluate the Overall Response Rate (CR/PR) rate according to RECIST V 1.1
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Overall Survival
Time Frame: 2 years
|
The interval between start of treatment and death from any cause
|
2 years
|
Median Progression Free Survival
Time Frame: 2 years
|
The interval between start of treatment and date of progression, or death, from any cause
|
2 years
|
Median Duration of response
Time Frame: 2 years
|
2 years
|
|
Health-related quality-of-life scores per patient measured according to the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C-30 scoring manual
Time Frame: 2 years
|
2 years
|
|
Health-related quality-of-life scores per patient measured according to the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) H&N35 scoring manual
Time Frame: 2 years
|
2 years
|
|
Number of participants with adverse events
Time Frame: 2 years
|
AEs, treatment-related AEs, serious adverse events (SAEs), and treatment-related SAEs will be tabulated using worst grade per NCI CTCAE v 5.0 criteria.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thorsten Fuereder, MD, Medical University of Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2020
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 19, 2020
First Posted (Actual)
February 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Paclitaxel
- Cetuximab
Other Study ID Numbers
- PACE ACE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Squamous Cell Carcinoma
-
Washington University School of MedicineMerck Sharp & Dohme LLCActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Carcinoma, Squamous Cell of Head and Neck | Neoplasms, Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
-
Chase Heaton, MDIncyte Corporation; OncoSec Medical IncorporatedTerminatedRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell Carcinoma | Unresectable Head and Neck Squamous Cell CarcinomaUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Advanced Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell Carcinoma | Locally Advanced Head and Neck Squamous Cell Carcinoma | Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage IV Cutaneous...United States
-
Washington University School of MedicineActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
-
Yonsei UniversityCompletedHead Neck Cancer Squamous Cell Recurrent | Head Neck Cancer Squamous Cell MetastaticKorea, Republic of
-
Xiang LuRecruitingHead and Neck Squamous Cell Carcinomas | Resectable Head and Neck Squamous-cell CarcinomaChina
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingHead and Neck Squamous Cell Carcinoma | Recurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell CarcinomaUnited States
-
Medical College of WisconsinRecruitingResectable Head and Neck Squamous Cell CarcinomaUnited States
-
Eben RosenthalNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN)United States
-
Shanghai Ninth People's Hospital Affiliated to...RecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell CarcinomaChina
Clinical Trials on Paclitaxel
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7 | Metastatic Breast Carcinoma | Locally Advanced Breast CarcinomaUnited States
-
Anne NoonanNational Cancer Institute (NCI)RecruitingStage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic AdenocarcinomaUnited States
-
Hutchison Medipharma LimitedSun Yat-sen UniversityActive, not recruitingAdvanced Gastric CancerChina
-
University of WashingtonNational Cancer Institute (NCI); Celgene CorporationCompletedRecurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung CancerUnited States
-
Shengjing HospitalRecruiting
-
CTI BioPharmaTerminatedNSCLCUnited States, Canada, Bulgaria, Romania, Russian Federation, Ukraine, Mexico, Argentina, Hungary, Poland, United Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Urothelial Carcinoma | Stage IV Bladder Urothelial CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
CTI BioPharmaTerminated
-
Novartis PharmaceuticalsCompletedMetastatic or Locally Advanced Solid TumorsNetherlands, Spain, Germany, Switzerland, Belgium