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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00494182
First received: June 28, 2007
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Head and Neck Cancer
Squamous Cell Carcinoma
Drug: Sorafenib
Drug: Carboplatin
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Objective Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib + Carboplatin + Paclitaxel
Sorafenib 400 mg by mouth twice daily on Day 2-19. Carboplatin 6 AUC by vein over 30 Minutes On Day 1. Paclitaxel 200 mg/m^2 by vein 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 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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494182

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bayer
Investigators
Principal Investigator: George Blumenschein, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00494182     History of Changes
Other Study ID Numbers: 2006-0940, NCI-2010-00623
Study First Received: June 28, 2007
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Carboplatin
Paclitaxel
Sorafenib
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014