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NCT00513435 · REGISTRY CONDITION SEARCH

Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2014-04-30

This phase II trial is studying the how well saracatinib works in treating patients with metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: saracatinib
    2. Other: laboratory biomarker analysis
    label
    Treatment (enzyme inhibitor therapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (enzyme inhibitor therapy)
    description
    Given PO
    name
    saracatinib
    other Names
    1. AZD0530
    type
    DRUG
  2. arm Group Labels
    1. Treatment (enzyme inhibitor therapy)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
9
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Response was determined as inicated in the protocol.
    measure
    Overall Response Rate
    time Frame
    From the start of treatment for up to 12 weeks
secondary Outcomes
  1. description
    The Kaplan-Meier method will be used to estimate overall survival.
    measure
    Overall Survival
    time Frame
    Up to 12 weeks
Full study description
brief Summary
This phase II trial is studying the how well saracatinib works in treating patients with metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
detailed Description
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.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      query cond
      Metastatic Squamous Neck Cancer With Occult Primary
      query disease state id
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      source file
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      query disease state id
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    Preserved source evidence · Not medical advice