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Monoclonal Antibodies
Chemotherapy + Bevacizumab for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Ahmad Wehbe, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with AJCC 7th edition stage III-IVB head and neck cancer, all sites, including unknown primary tumors
Prior to entry in the study the resectability and alternative treatment options for each patient will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. The unequivocal demonstration of distant metastasis (M1) confers ineligibility
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks up to 10 years
Awards & highlights
Study Summary
This trial is testing a new combination of chemotherapy drugs and radiation for squamous cell carcinoma of the head and neck. The goal is to find out how well it works and what side effects it has.
Who is the study for?
Adults over 18 with stage III-IVB head and neck cancer, who haven't had chemotherapy or radiation for it. They must have a certain level of physical fitness (ECOG 0-1), no distant metastasis, and not be on other trials. HPV status must be known, and they should agree to provide tissue samples. Blood counts, liver function, kidney function (creatinine clearance ≥60 ml/min), and urine protein levels need to meet specific criteria.Check my eligibility
What is being tested?
The trial tests how well patients respond to a combination of drugs: Docetaxel, Cisplatin, Cetuximab plus Bevacizumab followed by radiation therapy with the same drugs. It aims to see if this can improve survival rates without the disease getting worse. The study also looks at biomarkers in tumor biopsies before and after treatment.See study design
What are the potential side effects?
Possible side effects include allergic reactions related to docetaxel or compounds like it; bleeding issues; high blood pressure events; heart problems such as congestive heart failure; wounds that don’t heal properly; gastrointestinal complications like fistulas or perforations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head or neck cancer is at an advanced stage.
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My cancer's treatment plan was reviewed by a specialized team and I don't have cancer spread to distant parts.
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My cancer is confirmed to be a specific type affecting the nasopharynx.
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I have not had any treatments targeting my head or neck cancer.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My recent urine test shows normal protein levels.
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I had skin or cervical cancer but was treated for it, or I've been free from any other cancer for 3 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Response
Secondary outcome measures
Level of Angiogenesis Biomarkers
Side effects data
From 2022 Phase 2 trial • 3 Patients • NCT01588431100%
Low HbA1c
100%
Neutrofever
67%
Decreased White Blood Cell count
67%
Skin Rash
67%
Anorexia
33%
Neutropenia
33%
Anemia
33%
Weight loss
33%
Appendicitis
33%
Atrial fibrillation
33%
Transaminase imbalance
33%
Decreased platelet count
33%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
(TPE-A) Followed by Concurrent RT(XPE-A), Surgery
Trial Design
1Treatment groups
Experimental Treatment
Group I: (TPE-A) Followed by Concurrent RT(XPE-A), surgeryExperimental Treatment1 Intervention
Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery
2011
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,411 Total Patients Enrolled
Ahmad Wehbe, MDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious wound or bone fracture that is not healing.I've only had minor surgery for my cancer, more than 4 weeks ago but less than 3 months ago.My head or neck cancer is at an advanced stage.I haven't had a stroke or mini-stroke in the last 6 months.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I am 18 years old or older.I am fully active or can carry out light work.I am severely allergic to docetaxel or similar drugs.My cancer's treatment plan was reviewed by a specialized team and I don't have cancer spread to distant parts.My tumor has been tested for HPV, and I agree to provide tissue and blood samples for further study.I will have an EKG, and if it shows heart issues, I'll see a cardiologist before starting the study.I have not had a gut perforation or abnormal connection in my belly in the last 6 months.I had skin or cervical cancer but was treated for it, or I've been free from any other cancer for 3 years.I do not have HIV.You have had a serious allergic reaction to a type of medication called monoclonal antibodies, or you are known to be hypersensitive to any ingredient in bevacizumab.I do not have any ongoing illnesses or social situations that would stop me from following the study's requirements.I have not had a biopsy or minor surgery in the last 7 days, except for getting a device for vein access.My cancer is confirmed to be a specific type affecting the nasopharynx.I do not have significant nerve damage or weakness.My tumor is HPV positive and I have smoked 10 or fewer pack-years.I have had a severe hypertension crisis or brain issues due to high blood pressure.I haven't had major blood vessel problems or surgeries in the last 6 months.I have coughed up a noticeable amount of bright red blood recently.I am not on blood thinners, except possibly a low dose of warfarin, and my blood clotting time is normal.I am taking anti-platelet drugs but not aspirin or NSAIDs that affect platelet function.I have not had any treatments targeting my head or neck cancer.I understand the treatment details and am willing to sign the consent form.I do not have a bleeding disorder or significant blood clotting issues.I haven't had a heart attack or unstable chest pain in the last year.My recent urine test shows normal protein levels.I have heart failure that affects my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: (TPE-A) Followed by Concurrent RT(XPE-A), surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned TPE-A followed by XPE-A, surgery as a treatment regimen?
"There is some clinical evidence supporting the safety of Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery which earned it a rating of 2. However there isn't enough data to demonstrate efficacy."
Answered by AI
What medical condition is typically treated with the Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery protocol?
"For the treatment of head and neck tumours, as well as soft tissue sarcoma (STS), recurrent platinum-sensitive epithelial ovarian cancer, and malignant neoplasms, Docetaxel, Cisplatin, Cetuximab and Bevacizumab in tandem with radiation therapy followed by surgery is frequently recommended."
Answered by AI
How many participants are being observed in this research endeavor?
"This particular study has ceased recruitment, with its initial post-date being December 1st 2011 and the last update on December 15th 2021. Nevertheless, there are still 1068 trials for head neoplasms and 1336 studies revolving around Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery that require volunteers to participate."
Answered by AI
Is there an ongoing recruitment of participants for this research?
"At this moment, the medical study is not accepting participants. Initially published on December 1st 2011 and recently updated on December 15th 2021, it does not currently meet its recruitment needs. Fortunately, 1068 clinical trials for head neoplasms and 1336 studies involving Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery are actively recruiting patients at present."
Answered by AI
Are there any recorded instances of the TPE-A and XPE-A treatments, followed by surgery, being conducted with Docetaxel, Cisplatin, Cetuximab and Bevacizumab?
"As of now, 1336 clinical trials evaluating Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery are actively underway with the majority of them being held in Shanghai. There are 454 Phase 3 studies out of 77149 locations for this particular medical intervention."
Answered by AI
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