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A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)


OBJECTIVES:

Primary

- To determine the median progression-free survival for patients with advanced or
recurrent squamous cell carcinoma of the head and neck (HNSCC) treated with AZD0530.

Secondary

- To determine overall survival for patients with advanced or recurrent HNSCC treated
with AZD0530.

- To determine objective response rate for patients with advanced or recurrent HNSCC
treated with AZD0530.

OUTLINE: Patients receive AZD0530 orally or by percutaneous endoscopic gastrostomy (PEG)
tube once daily on days 1-56. Treatment repeats every 8 weeks in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 12 weeks and then
periodically thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

- Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck

- Persistent, recurrent, or metastatic disease that is not amenable to
curative-intent therapy with surgery or radiation

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional
techniques or ≥ 10 mm with spiral CT scan

Exclusion criteria:

- Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Karnofsky performance status ≥ 60%

- WBC ≥ 3,000/mcL

- Absolute neutrophil count ≥ 1,500/mcL

- Platelets ≥ 100,000/mcL

- Hemoglobin > 9 g/dL

- Total bilirubin within upper institutional limits of normal (ULN)

- AST/ALT ≤ 2.5 x ULN

- Creatinine within ULN OR creatinine clearance ≥ 60 mL/min

- Patients must agree to use adequate birth control for the duration of study
participation and for at least 8 weeks after discontinuation of study drug

Exclusion criteria:

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to AZD0530

- Urine protein:creatinine ratio ≥ 1.0 OR 24-hour urine protein ≥ 1,000 mg

- QTc prolongation ≥ 480 msecs

- Intercurrent symptomatic congestive heart failure, unstable angina pectoris, or
cardiac arrhythmia

- History of myocardial infarction within the past year

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or breastfeeding women

- HIV-positive patients on combination antiretroviral therapy

- Pulmonary fibrosis ≥ grade 2, pleural effusion (non-malignant) ≥ grade 2, or
pneumonitis/pulmonary infiltrates ≥ grade 2

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- May have received 1 prior cytotoxic chemotherapy regimen for recurrent or metastatic
disease

Exclusion criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study

- Patients who have not recovered from adverse events due to agents administered more
than 4 weeks earlier

- Use of specifically prohibited CYP3A4-active agents or substances

- Prohibited drugs should be discontinued 7 days prior to the administration of
the first dose of AZD0530 and for 7 days following discontinuation of AZD0530

- Patients receiving any other investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Matthew G. Fury, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

Unspecified

Study ID:

CDR0000559632

NCT ID:

NCT01664468

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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