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

NCT00494182 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2006-0940NCI-2018-01836
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Squamous Cell Carcinoma of the Hypopharynx; Metastatic Squamous Cell Carcinoma of the Larynx; Metastatic Squamous Cell Carcinoma of the Oral Cavity; Metastatic Squamous Cell Carcinoma of the Oropharynx; Recurrent Head and Neck Squamous Cell Carcinoma; Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Oral Cavity Squamous Cell Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Metastatic Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

• Objective overall response rate

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

  Up to 12 years

• 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.

  Up to 12 years

• 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.

  Up to 12 years

• 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.

  Up to 12 years

Study Arms (1)

Treatment (carboplatin, paclitaxel, sorafenib)

EXPERIMENTAL

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.

Drug: Carboplatin; Drug: Paclitaxel; Drug: Sorafenib

Interventions

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (carboplatin, paclitaxel, sorafenib)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (carboplatin, paclitaxel, sorafenib)

Sorafenib DRUG

Given PO

Also known as: BAY 43-9006

Treatment (carboplatin, paclitaxel, sorafenib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Carboplatin; Paclitaxel; Taxes; Sorafenib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• George Blumenschein, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: April 25, 2007
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)