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Metastatic Head and Neck Squamous Cell CarcinomaPhase 2NCT00494182

Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

A Phase 2 study testing Carboplatin, Paclitaxel and Sorafenib in people with Metastatic Head and Neck Squamous Cell Carcinoma and Metastatic Squamous Cell Carcinoma of the Hypopharynx, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies how well sorafenib works with carboplatin and paclitaxel in treating participants with head and neck squamous cell cancer that has spread to other parts of the body or that has come back. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Paclitaxel and Sorafenib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
25 Apr 2007to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  • Patients must have cytologically or histologically proven recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) from the primary tumor or lymph nodes of the oral cavity, larynx, oropharynx, or hypopharynx.
  • No prior systemic chemotherapy for patients who present with metastatic disease. For patients with recurrent head and neck squamous cell carcinoma, prior chemotherapy is allowed if it was given as part of their definitive therapy. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.
  • Patients must have at least 1 evaluable lesion. Lesions must be evaluated by computed Tomography (CT) scan or magnetic resonance imaging (MRI).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
  • Controlled blood pressure (defined as systolic blood pressure [BP] =< 140 mmHg and diastolic =< 85 mmHg).
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  • Hemoglobin >= 9.0 g/dL within 7 days prior to start of first dose.
  • Absolute neutrophil count (ANC) >= 1,500/mm^3 within 7 days prior to start of first dose.
  • Platelet count >= 100,000/mm^3 within 7 days prior to start of first dose.
  • Total bilirubin =< 1.5 times the upper limit of normal (ULN) within 7 days prior to start of first dose.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for patients [pts] with [w/] liver involvement) within 7 days prior to start of first dose.
  • International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) within (w/in) normal limits within 7 days prior to start of first dose.
  • 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.
  • Amylase \& lipase < 1.5 x the ULN within 7 days prior to start of first dose.
  • Urinalysis (UA) must show less than 1+ protein in urine, or the pt will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required \& must show total protein =< 1000 mg/24 hour to be eligible.
  • Women of childbearing potential (not surgically sterilized or at least 2 years postmenopausal) must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment.
  • Women of childbearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and 3 months after end of treatment. Should a woman become pregnant while participating or the partner of a patient participating in this study becomes pregnant, they should inform their treating physician immediately.

Who cannot join

  • Congestive heart failure (CHF) > class II New York Heart Association (NYHA); active coronary artery disease (myocardial infarction [MI] more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  • Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 85 mmHg despite optimal medical management.
  • Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
  • Active clinically serious infections (i.e. patients currently taking antibiotics) (grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events (CTCAE) version 3.0).
  • Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis.
  • Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism. History of transient ischemic attack is allowed.
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  • Evidence or history of bleeding diathesis or coagulopathy.
  • History of/or current evidence of hemoptysis (bright red blood of ½ teaspoon or more).
  • Peripheral neuropathy >= grade 2 (NCI-CTC version 3.0).
  • Anticancer chemotherapy or immunotherapy: anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints.
  • Radiotherapy to the target lesions within 3 weeks of start of first dose. Toxicities from radiotherapy must have resolved prior to start of first dose.
  • No major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Granulocyte growth factors (G-CSF), within 3 weeks of study entry.
  • Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.
  • Pregnant or breastfeeding patients.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • Known or suspected allergy to any recombinant human antibodies, or compounds of similar chemical or biologic composition to sorafenib or any of the drugs in this study.
  • Any condition that is unstable or could jeopardize the safety or compliance of the patient in the study.
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the study EXCEPT cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to study entry.
  • Known or suspected allergy to sorafenib (BAY 43-9006) or any agent given in association with this trial.
  • Any malabsorption conditions.
  • Therapeutic anticoagulation with warfarin, heparins, or heparinoids.
  • Patients taking phenytoin, carbamazepine, and phenobarbital.
  • Patients taking rifampin and/or St. John's Wort.
  • Patients who are candidates for curative surgery or radiotherapy.
  • The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer

This phase II trial studies how well sorafenib works with carboplatin and paclitaxel in treating participants with head and neck squamous cell cancer that has spread to other parts of the body or that has come back. Drugs used in chemotherapy, such as sorafenib, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the progression free survival of the combination of sorafenib (BAY 43-9006), carboplatin, and paclitaxel in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).

SECONDARY OBJECTIVES:

  1. Response rate, toxicity, safety profile, exploratory biomarker data, and overall survival.

OUTLINE:

Participants receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3 hours on day 1, and sorafenib orally (PO) twice daily (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.

After completion of study treatment, participants are followed up between 21-35 days.

Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • SorafenibDrug

    Also called BAY 43-9006

    Given PO

Study groups in NCT00494182
Study groupRoleWhat they receive
Treatment (carboplatin, paclitaxel, sorafenib)ExperimentalParticipants 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.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective overall response rate

    The rate of response to the treatment will be estimated, and the 95% confidence interval will be calculated.

    Measured: Up to 12 years

  2. Time to progression

    Kaplan-Meier estimates of time to progression will be provided. Time to progression will be calculated from the first date of receiving study drug until documented progressive disease. Participants without tumor progression at the time of analysis will be censored at the date of their last tumor assessment. Log-rank test will be applied to test the differences in survivals between levels of prognostic factors.

    Measured: Up to 12 years

  3. Progression-free survival

    Kaplan-Meier estimates of progression-free survival will be provided. Progression-free survival will be calculated from the first day of receiving study drug until documented progressive disease or death due to any cause (if death occurs before progression). Log-rank test will be applied to test the differences in survivals between levels of prognostic factors.

    Measured: Up to 12 years

  4. Biomarkers

    The following biomarkers may be measured where appropriate, dependent on sample availability: phosphorylated ERK, phosphorylated VEFGR-2, p53 expression, CD31, CD34 and CD105 expression, HIF-1 alpha, HIF-2 alpha, Glut-1, CAIX, VHL and p53 mutational status, methylation status, blood cell RNA expression profiling, protein pattern profiling, Her-2, VEGF, and VEFGR2 expression. Correlation with clinical outcomes will be attempted. The association among various continuous and discrete variables will be assessed first by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot. Correlation among continuous variables will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete variables will be tested by Chi-square or Fisher's exact test.

    Measured: Up to 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2007 (estimated)
  2. Study start25 Apr 2007
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00494182
Sponsor's protocol ID
2006-0940
Other IDs
NCI-2018-01836, 2006-0940
Status last verified
Jun 2026
First submitted
28 Jun 2007
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and Sorafenib in people with Metastatic Head and Neck Squamous Cell Carcinoma and Metastatic Squamous Cell Carcinoma of the Hypopharynx, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective overall response rate (time frame: Up to 12 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00494182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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