Sorafenib Plus Carboplatin and Paclitaxel in Head and Neck Squamous Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00494182
Recruitment Status : Active, not recruiting
First Posted : June 29, 2007
Last Update Posted : August 17, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if the combination of carboplatin, paclitaxel, and sorafenib can help to control the disease in patients with head and neck cancer. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Squamous Cell Carcinoma Drug: Sorafenib Drug: Carboplatin Drug: Paclitaxel Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Actual Study Start Date : April 2007
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sorafenib + Carboplatin + Paclitaxel
Sorafenib 400 mg orally twice daily on Day 2-19. Carboplatin 6 AUC intravenously (IV) over 30 Minutes on Day 1. Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1.
Drug: Sorafenib
400 mg by mouth twice daily on Day 2-19
Other Name: BAY 43-9006
Drug: Carboplatin
6 area under the plasma drug concentration-time curve (AUC) by vein over 30 Minutes On Day 1
Other Name: Paraplatin
Drug: Paclitaxel
200 mg/m^2 by vein over 3 hours on Day 1
Other Name: Taxol

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 3 years ]
    Progression-free survival calculated from first day of receiving study drug until documented progressive disease or death due to any cause (if death occurs before progression). Patients without tumor progression or death at time of analysis, censored at date of last tumor assessment.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Age >/= 18 years
  5. Patients must have at least 1 evaluable lesion. Lesions must be evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI)
  6. ECOG Performance Status (PS) of 0-1
  7. Controlled blood pressure (defined as systolic BP </= 140 mmHg and diastolic </= 85 mmHg)
  8. Adequate bone marrow, liver & renal function as assessed by the following laboratory requirements to be conducted w/in 7 days prior to start of first dose: Hemoglobin >/= 9.0 g/dL; Absolute neutrophil count (ANC) >/= 1,500/mm^3; Platelet count >/= 100,000/mm^3; Total bilirubin </= 1.5 times the upper limit of normal (ULN);ALT and AST </= 2.5 x ULN (</= 5 x ULN for pts w/ liver involvement); INR </= 1.5 and PTT w/in normal limits
  9. Continued from Inclusion #8: Serum creatinine </= 1.5 ULN or creatinine clearance (CrCl) >/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for pts w/ creatinine levels above institutional normal; Amylase & lipase < 1.5 x the ULN; 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
  10. 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
  11. 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.

Exclusion Criteria:

  1. Cardiac disease: Congestive heart failure (CHF) > Class II 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)
  2. Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 85 mmHg despite optimal medical management
  3. Known history of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
  4. Active clinically serious infections (i.e. patients currently taking antibiotics)( Grade 2 NCI-CTC Version 3.0)
  5. Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis
  6. Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism. History of transient ischemic attack is allowed.
  7. Evidence or history of bleeding diathesis or coagulopathy
  8. History of/or current evidence of hemoptysis (bright red blood of ½ teaspoon or more)
  9. Peripheral neuropathy >/= Grade 2 (NCI-CTC Version 3.0)
  10. 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
  11. 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.
  12. No major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose
  13. Serious, non-healing wound, ulcer, or bone fracture
  14. Granulocyte growth factors (G-CSF), within 3 weeks of study entry.
  15. Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose.
  16. Pregnant or breastfeeding patients
  17. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  18. 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
  19. Any condition that is unstable or could jeopardize the safety or compliance of the patient in the study
  20. 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
  21. Known or suspected allergy to sorafenib (BAY 43-9006) or any agent given in association with this trial
  22. Any malabsorption conditions
  23. Therapeutic anticoagulation with warfarin, heparins, or heparinoids
  24. Patients taking phenytoin, carbamazepine, and Phenobarbital
  25. Patients taking rifampin and/or St. John's Wort
  26. Patients who are candidates for curative surgery or radiotherapy
  27. The patient has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00494182

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: George Blumenschein, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00494182     History of Changes
Other Study ID Numbers: 2006-0940
NCI-2010-00623 ( Registry Identifier: NCI CTRP )
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Squamous Cell Carcinoma
BAY 43-9006

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs