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Alkylating Agent
Sorafenib + Chemotherapy for Head and Neck Cancer
Phase 2
Waitlist Available
Led By George Blumenschein, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 1.5 ULN or creatinine clearance (CrCl) >= 45 mL/min for patients (pts) w/ creatinine levels above institutional normal within 7 days prior to start of first dose.
Patients must have at least 1 evaluable lesion. Lesions must be evaluated by computed Tomography (CT) scan or magnetic resonance imaging (MRI).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat head and neck squamous cell cancer.
Who is the study for?
This trial is for adults with recurrent or metastatic head and neck squamous cell cancer who haven't had systemic chemotherapy for metastatic disease, or if recurrent, have been off therapy for at least 6 months. They must be able to sign consent, have controlled blood pressure, adequate organ function, no major surgery recently, not pregnant or breastfeeding, and agree to use contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of sorafenib in combination with carboplatin and paclitaxel chemotherapy drugs on participants with advanced head and neck cancer. It aims to see how well these drugs work together in stopping tumor growth by killing cells or preventing them from dividing and spreading.See study design
What are the potential side effects?
Potential side effects include high blood pressure; bleeding risks; peripheral neuropathy (nerve pain); wound healing complications; heart issues like congestive heart failure; serious infections; thrombotic events (like strokes); allergic reactions to the medications used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range.
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I have at least one tumor that can be measured by CT or MRI.
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My urine protein levels are low enough for the trial.
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My cancer is a recurring or spreading type in my head or neck area.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biomarkers
Objective overall response rate
Progression-free survival
+1 moreSide effects data
From 2020 Phase 2 trial • 40 Patients • NCT0190000212%
AST increase
12%
Hypertension
9%
Hyponatremia
9%
Fatigue
6%
Vomiting
6%
Nausea
6%
Dizziness
6%
Diarrhea
6%
ALT increase
3%
Weight Loss
3%
Hypertenstion
3%
Duodenal Ulcer
3%
Sepsis
3%
Acute Renal Failure
3%
Hypotension
3%
Hypophosphatemia
3%
Hematuria
3%
Hepatic Hemorrhage
3%
Urinary Retention
3%
Dyspnea
3%
Weakness
3%
Abdominal Pain
3%
Rectal Bleed
3%
Palmar-Planta Erythrodysesthesia
3%
Thrombocytopenia
3%
Hyperbilirubinemia
3%
Proteinuria
3%
Mucositis
3%
Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Sorafenib Tosylate, TheraSphere)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (carboplatin, paclitaxel, sorafenib)Experimental Treatment3 Interventions
Participants receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1, and sorafenib PO BID on days 2-19. Treatment repeats every 21 days for up to 6 courses. Starting with course 7, participants receive sorafenib PO daily in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Sorafenib
2014
Completed Phase 3
~1670
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,754 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,619 Total Patients Enrolled
George Blumenschein, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
709 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery or a serious injury in the last 4 weeks.My kidney function is within the required range.I do not have severe heart failure or recent serious heart problems.I have a history of bleeding disorders.I have a history of brain-related health issues.I have had a stroke, deep vein thrombosis, or lung blood clot, but a minor stroke is okay.I have coughed up a noticeable amount of bright red blood recently.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have at least one tumor that can be measured by CT or MRI.My urine protein levels are low enough for the trial.I am a woman who can have children and have a recent negative pregnancy test.My high blood pressure is not controlled even with medication.I have a history of HIV or chronic hepatitis B or C.I have a condition that affects how my body absorbs nutrients.I am currently taking phenytoin, carbamazepine, or phenobarbital.I am not taking rifampin or St. John's Wort.I am fully active or can carry out light work.I am currently receiving or have received drugs to treat my cancer.I have a serious wound or fracture that is not healing.I haven't taken any granulocyte growth factors in the last 3 weeks.I do not have any serious infections requiring antibiotics.I have not had radiation on my cancer spots in the last 3 weeks and any side effects from past radiation have gone away.I have been on a stable dose of erythropoietin for the last 2 months.I am eligible for surgery or radiotherapy aimed at curing my condition.I have had cancer before, but it was a different type or treated over 3 years ago.I am on blood thinners like warfarin or heparin.My condition worsened within 6 months after finishing treatment meant to cure my localized or advanced disease.My cancer is a recurring or spreading type in my head or neck area.I haven't had chemotherapy for my metastatic disease, or if I had head/neck cancer, it was part of my initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (carboplatin, paclitaxel, sorafenib)
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.
For what medical purpose is Sorafenib typically prescribed?
"Sorafenib is a medication that dermatologists often prescribe to patients with melanoma. Additionally, this drug can ameliorate symptoms for those suffering from neoplasm metastasis, lymphoma, non-hodgkin, and advanced sarcoma."
Answered by AI
What is the FDA's stance on Sorafenib?
"Sorafenib's safety was given a score of 2 because, while there is data supporting its safety profile, there are no Phase 3 clinical trials indicating efficacy."
Answered by AI
How many individuals are signed up to participate in this experiment?
"Unfortunately, this particular trial is not seeking patients at the moment. It was originally posted on April 25th, 2007 but was edited most recently on April 27th, 2022. If you're interested in other trials, 3588 clinical studies are currently recruiting for carcinoma patients and 1286 for Sorafenib."
Answered by AI
Are researchers still looking for volunteers for this trial?
"As of 4/27/2022 this trial is no longer admitting patients. The study was initially posted on 4/25/2007. If you are looking for other trials, there are currently 3588 cancer studies and 1286 Sorafenib trials actively enrolling participants."
Answered by AI
What other clinical research has been conducted with Sorafenib?
"Currently, there are 1286 clinical trials underway that are investigating the efficacy of sorafenib. Of these trials, 364 are in phase 3. The majority of these studies are being conducted in Shanghai, China; however, there are 69528 locations worldwide where these trials are taking place."
Answered by AI
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