Clinical Trials /

Expansion Trial for Axitinib In Head And Neck Cancer

NCT02762513

Description:

This study will be a prospective, single-institution, single-arm phase II study of Axitinib in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma. The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression or intolerable toxicity.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Expansion Trial for Axitinib In Head And Neck Cancer
  • Official Title: Phase II Expansion Trial for Axitinib In Head And Neck Cancer

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2016.040
  • SECONDARY ID: HUM00114022
  • NCT ID: NCT02762513

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DrugSynonymsArms
AxitinibAxitinib

Purpose

This study will be a prospective, single-institution, single-arm phase II study of Axitinib in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma. The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression or intolerable toxicity.

Trial Arms

NameTypeDescriptionInterventions
AxitinibExperimentalParticipants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
  • Axitinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically documented squamous cell head and neck cancer with or without
             metastases, not amenable to curative treatment; or the patient has documented refusal
             of curative treatment.

          -  Presence of measurable disease by CT scan.

          -  Adequate bone marrow, hepatic, and renal function

          -  Age ≥18 years.

          -  ECOG (Eastern Cooperative Oncology Group scoring system used to quantify general
             well-being and activities of daily life; scores range from 0 to 5 where 0 represents
             perfect health and 5 represents death.) performance status of 0-2.

          -  Life expectancy of ≥12 weeks.

          -  No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood
             pressure readings taken at least 30 minutes apart. Patients whose hypertension is
             controlled by antihypertensive therapies are eligible.

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

          -  Signed and dated informed consent

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

          -  If a curative treatment option in the form of chemoradiation exists in a patient with
             unresectable disease, this has to be attempted first and must have failed, unless the
             patient has documented refusal of curative treatment.

        Exclusion Criteria:

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

          -  Active hemoptysis

          -  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.

          -  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.

          -  Current use or anticipated inability to avoid use of drugs that are known potent
             CYP3A4/5 inhibitors

          -  Current use or anticipated inability to avoid use of drugs that are known CYP3A4/5
             inducers

          -  Active seizure disorder or evidence of untreated or progressive brain metastases,
             spinal cord compression, or carcinomatous meningitis (Subjects with brain metastases
             are eligible if they have been treated and there is no CT or MRI evidence for at least
             4 weeks after CNS (Central Nervous System) metastasis treatment is complete.).

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

          -  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.

          -  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.

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

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

          -  Women who are pregnant or breast-feeding.

          -  Patients with history of bleeding diathesis, 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.

          -  Patients residing in prison.

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

          -  HIV virus infection irrespective of viral load, treatment status, or CD4 count, or
             acquired immunodeficiency syndrome (AIDS)-related illness. HIV testing is not required
             by this protocol.

          -  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
             attack.

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

          -  Availability of curative treatment option for the patient's cancer, whether surgery,
             chemotherapy, radiation, or combination thereof, unless the patient has documented
             refusal of curative treatment.

          -  Increased risk of wound dehiscence or presence of non-healing wounds.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants Alive at 6 Months
Time Frame:6 Months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Median Overall Survival Time
Time Frame:6 Months
Safety Issue:
Description:
Measure:Median Progression Free Survival Time
Time Frame:6 Months
Safety Issue:
Description:
Measure:The Number of Patients with an Objective Response
Time Frame:16 Weeks
Safety Issue:
Description:The number of patients with Complete Response (CR) or Partial Response (PR) at 16 weeks. CR is defined as no new lesions and the disappearance of all lesions. PR is defined as a decrease in size1 of ≥ 10% or a decrease in tumor density (HU) ≥ 15% on CT (Computerized Tomography), no new lesions and no obvious progression of non-measurable disease
Measure:The Number of Patients that Experience Grade 3 or Worse Toxicities
Time Frame:6 Months
Safety Issue:
Description:The investigator will use the following definitions of severity in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 to describe the maximum intensity of the adverse event: Grade 3 - severe adverse event Grade 4 - life-threatening or disabling adverse event Grade 5 - death related to adverse event

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Michigan Rogel Cancer Center

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