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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Squamous Cell Carcinoma

Thank you

Trial Information

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


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.

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 40 patients will take part in
this study. All will be enrolled at M. D. Anderson.


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 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 AST w/in normal limits

9. Continued from Inclusion #8: Serum creatinine (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
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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Overall Response Rate

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

George Blumenschein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0940

NCT ID:

NCT00494182

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Sorafenib
  • BAY 43-9006
  • Carboplatin
  • Paclitaxel
  • SCCHN
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030