Sorafenib Plus Carboplatin and Paclitaxel in Head and Neck Squamous Cell Cancer
This trial is active, not recruiting.
|Conditions||head and neck cancer, squamous cell carcinoma|
|Treatments||sorafenib, carboplatin, paclitaxel|
|Targets||RAF, FLT-3, KIT, PDGF, VEGF|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||April 2007|
|End date||April 2019|
|Trial size||42 participants|
|Trial identifier||NCT00494182, 2006-0940, NCI-2010-00623|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 3 years
Male or female participants at least 18 years old.
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.
|Official title||A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer|
|Principal investigator||George Blumenschein, MD|
|Description||The Study Drugs: Sorafenib is a drug that is designed to block the function of important proteins in cancer cells. These proteins, when active, are in part responsible for the abnormal growth and behavior of cancer cells. Carboplatin and paclitaxel are designed to work by stopping the division of cancer cells. Study Drug Administration: If you are found to be eligible to take part in this study, you will begin receiving sorafenib, carboplatin, and paclitaxel. On Day 1, paclitaxel will be given through a needle in your vein over 3 hours, followed by carboplatin by vein over 30 minutes. On Days 2-19, you will take sorafenib by mouth or by stomach tube. You will take 2 tablets of sorafenib each morning, and again each evening. Sorafenib should be taken with about 1 cup (8 ounces) of water on an empty stomach (either 1 hour before a meal or 2 hours after a meal). Sorafenib must be swallowed whole without chewing or prepared using instructions provided on the patient handout for preparing sorafenib as a liquid. If you miss a dose, you should skip it and take the next scheduled dose at the scheduled time. Every 21 days is called a study "cycle". You may be given medications before receiving the study drugs to decrease the risk of nausea and allergic reaction. Study Visits: On Days 1, 8, and 15 of Cycle 1 you will have the following tests and procedures performed: - You will have a physical exam. - Blood (about 1-2 teaspoons) and urine will be collected for routine tests. - You will have a performance status evaluation. - Blood (about 1-2 tablespoons) will be drawn to check to see how well your blood clots. On Day 1 of Cycles 2 and beyond, you will have the following tests and procedures performed: - You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). - Blood (about 2 teaspoons) and urine will be collected for routine tests. - You will have a performance status evaluation. - Blood (about 1-2 teaspoons) will be drawn to check how well your blood clots. Every week for the first 6 weeks on study treatment, you will measure and record your blood pressure. The study staff will explain to you how to measure your blood pressure. The study doctor or research nurse will review the log at each clinic visit. On Day 1 of every odd cycle (Cycles 3 and 5), you will have a chest x-ray and CT or MRI scans to check the status of the disease. If your doctor thinks it is needed, you will also have a bone scan. Length of Study: You may receive up to 6 cycles of treatment with the 3 study drugs. However, you may continue receiving sorafenib for as long as you are benefitting. You will be taken off study early if the disease gets worse or intolerable side effects occur. Study Visits for Sorafenib Treatment Only: If you continue to receive sorafenib after you have finished with the 6 cycles of treatment with the 3 study drugs, you will take the sorafenib every day. You will have study visits every 8 weeks. At these visits, you will have the following tests and procedures performed: - You will have a physical exam. - Blood (around 2 teaspoons) and urine will be collected for routine tests. - You will have a performance status evaluation. - Blood (about 1-2 teaspoons) will be drawn to check how well your blood clots. - You will have a chest x-ray and CT or MRI scan to check the status of the disease every 2 cycles. End-of-Study Visit: At the end of study treatment, you will have the following tests and procedures performed: - Your complete medical history will be recorded. - You will have a physical exam. - Blood (around 2 teaspoons) and urine will be collected for routine tests. - Blood (about 1-2 teaspoons) will be drawn to check how well your blood clots. - You will have a performance status evaluation. - You will have a chest x-ray and CT or MRI scan to check the status of the disease. - You will also have an ECG. This is an investigational study. Sorafenib is FDA approved for treatment of advanced renal cell cancer. Its use in this study, for this disease, is investigational. Carboplatin and paclitaxel are FDA approved and commercially available. Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.|
Call for more information