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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
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

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Trial Information

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


PRIMARY OBJECTIVES:

I. 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 (saracatinib).

SECONDARY OBJEC TIVES:

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

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

III. For patients with accessible tumors, to perform pre and post-treatment biopsies to
assess the pharmacodynamic effects of AZD0530 on c-Src and downstream signaling molecules
STAT3 and STAT5.

OUTLINE:

Patients receive saracatinib orally (PO) or by percutaneous endoscopic gastrostomy (PEG)
tube once daily (QD) on days 1-56. Courses repeat every 8 weeks in the absence of disease
progression or unacceptable toxicity.

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


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 computed tomography (CT) scan

- Karnofsky performance status ≥ 60%

- White blood cell (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)

- Aspartate aminotransferase (AST) /alanine aminotransferase (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

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

Exclusion Criteria:

- Known brain metastases

- 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

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy

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

- 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 cytochrome P450 3A4 (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:

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

Outcome Measure:

Progression-free survival

Outcome Description:

Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression-free survival (PFS) is measured from the date of first treatment to the date of disease progression or death. The Kaplan-Meier method will be used to estimate PFS.

Outcome Time Frame:

From the start of treatment for up to 12 weeks

Safety Issue:

No

Principal Investigator

Matthew Fury

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00192

NCT ID:

NCT00513435

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Nasopharynx
  • Stage III Squamous Cell Carcinoma of the Oropharynx
  • Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage III Verrucous Carcinoma of the Larynx
  • Stage III Verrucous Carcinoma of the Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IVA Squamous Cell Carcinoma of the Larynx
  • Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Oropharynx
  • Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Verrucous Carcinoma of the Larynx
  • Stage IVA Verrucous Carcinoma of the Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Larynx
  • Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Oropharynx
  • Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVB Verrucous Carcinoma of the Larynx
  • Stage IVB Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Larynx
  • Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Oropharynx
  • Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Verrucous Carcinoma of the Larynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Tongue Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Tongue Neoplasms
  • Carcinoma, Verrucous
  • Neoplasms, Unknown Primary
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021