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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).

Must not have

Evidence or history of bleeding diathesis or coagulopathy.

Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of bleeding disorders.

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I have a history of brain-related health issues.

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I have coughed up a noticeable amount of bright red blood recently.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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My high blood pressure is not controlled even with medication.

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I have a history of HIV or chronic hepatitis B or C.

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I do not have any serious infections requiring antibiotics.

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I am currently receiving or have received drugs to treat my cancer.

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I have not had radiation on my cancer spots in the last 3 weeks and any side effects from past radiation have gone away.

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I have a serious wound or fracture that is not healing.

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I am on blood thinners like warfarin or heparin.

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I am eligible for surgery or radiotherapy aimed at curing my condition.

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I have a condition that affects how my body absorbs nutrients.

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I am currently taking phenytoin, carbamazepine, or phenobarbital.

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I am not taking rifampin or St. John's Wort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Biomarkers

Objective overall response rate

Progression-free survival

+1 more

Side effects data

From 2020 Phase 2 trial • 40 Patients • NCT01900002

12%

AST increase

12%

Hypertension

Hyponatremia

Fatigue

ALT increase

Vomiting

Nausea

Dizziness

Diarrhea

Hypophosphatemia

Mucositis

Encephalopathy

Weight Loss

Hypertenstion

Duodenal Ulcer

Sepsis

Acute Renal Failure

Hypotension

Hematuria

Hepatic Hemorrhage

Urinary Retention

Dyspnea

Weakness

Abdominal Pain

Rectal Bleed

Palmar-Planta Erythrodysesthesia

Thrombocytopenia

Hyperbilirubinemia

Proteinuria

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Sorafenib Tosylate, TheraSphere)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120

Sorafenib

2014

Completed Phase 3

~2340