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Phase II Trial Evaluating Axitinib (AG-013736) In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer

Phase 2
18 Years
Open (Enrolling)
Head and Neck Squamous Cell Carcinoma

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Trial Information

Phase II Trial Evaluating Axitinib (AG-013736) In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer

Inclusion Criteria:

1. Histologically documented squamous cell head and neck cancer with or without
metastases, not amenable to curative treatment.

2. Presence of measurable disease by CT scan.

3. Adequate bone marrow, hepatic, and renal function (including absence of proteinuria,
PT (Prothrombin Time) <1.5, WBC (White Blood Cell count)≥ 3x109 cells/ml, ANC
(Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3,
hemoglobin ≥ 9.0 g/dL, concentrations of total serum bilirubin within 1.5 x upper
limit of normal (ULN), AST (Aspartate Aminotransferase), ALT (Alanine
Aminotransferase) within 2.5x institutional upper limits of normal unless there are
liver metastases in which case AST and ALT within 5.0 x ULN, serum creatinin
clearance ≥ 60 ml/min), urinary protein <2+ by urine dipstick (if dipstick is ≥2+
then a 24-hour urine collection can be done and the patient may enter only if urinary
protein is <2 g per 24 hours), documented within 14 days prior to initiation of
Axitinib treatment.

4. Age ≥18 years.

5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.

6. Life expectancy of ≥12 weeks.

7. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline
blood pressure readings taken at least 30 minutes apart. The baseline systolic blood
pressure readings must be ≤140 mm Hg, and the baseline diastolic blood pressure
readings must be ≤90 mm Hg. Patients whose hypertension is controlled by
antihypertensive therapies are eligible.

8. Women of childbearing potential must have a negative serum or urine pregnancy test
within 3 days prior to treatment.

9. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment.

10. Willingness and ability to comply with scheduled visits, treatment plans, including
willingness to take Axitinib, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Central lung lesions involving major blood vessels (arteries or veins) or a tumor
encasing major blood vessels (i.e. carotid artery).

2. History of hemoptysis.

3. Gastrointestinal abnormalities causing impaired absorption requiring intravenous
alimentation, prior surgical procedures affecting absorption including gastric
resection, treatment for active peptic ulcer disease in the past 6 months, active
gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis,
hematochezia or melena in the past 3 months without evidence of resolution documented
by endoscopy or colonoscopy, malabsorption syndromes.

4. Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors
of epidermal growth factor (EGF), platelet derived growth factor (PDGF), or
fibroblast growth factors (FGF) receptors within 30 days preceding study entrance.

5. Current use or anticipated inability to avoid use of drugs that are known potent
CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole,
itraconazole, erythromycin, clarithromycin, telithromycin, ergot derivatives,
indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir,
fosamprenavir , and delavirdine).

6. Current use or anticipated inability to avoid use of drugs that are known CYP3A4 or
CYP1A2 inducers (ie, carbamazepine, felbamate, omeprazole, phenobarbital, phenytoin,
amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).

7. Active seizure disorder or evidence of brain metastases, spinal cord compression, or
carcinomatous meningitis.

8. A serious uncontrolled medical disorder or active infection that would impair their
ability to receive study treatment.

9. History of a malignancy (other than head and neck cancer) except those treated with
curative intent for skin cancer (other than melanoma), in situ breast or in situ
cervical cancer, or those treated with curative intent for any other cancer with no
evidence of disease for 2 years.

10. Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is
at least one measurable lesion that has not been irradiated.

11. Dementia or significantly altered mental status that would prohibit the understanding
or rendering of informed consent and compliance with the requirements of this

12. Patients (male and female) having procreative potential who are not willing or not
able to use adequate contraception or practicing abstinence.

13. Women who are pregnant or breast-feeding.

14. History of prior treatment with more than 2 lines of therapy for metastatic head and
neck cancer.

15. Patients with history of bleeding diathesis, DVT (deep venous thrombosis) or arterial
thromboembolism, current use of therapeutic anticoagulation with oral vitamin K
antagonists, factor Xa inhibitors, heparin products, oral direct thrombin inhibitors,
or presence of non-healing wounds. Low-dose anticoagulants for maintenance of patency
of central venous access device or prevention of deep venous thrombosis is allowed.

16. Patients residing in prison.

17. Prior experimental therapy within 30 days of planned start of this trial.

18. HIV virus infection irrespective of viral load, treatment status, or CD4 count, or
acquired immunodeficiency syndrome (AIDS)-related illness.

19. Any of the following within the 12 months prior to study drug administration:
myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident or transient ischemic

20. History of deep vein thrombosis or pulmonary embolism within 6 month of anticipated
starting of Axitinib.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate

Outcome Description:

To determine the 6-months progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Francis P Worden, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:

UMCC 2011.053



Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752