search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
saracatinib
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (enzyme inhibitor therapy)

Arm 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.

Outcomes

Primary Outcome Measures

Overall Response Rate
Response was determined as inicated in the protocol.

Secondary Outcome Measures

Overall Survival
The Kaplan-Meier method will be used to estimate overall survival.

Full Information

First Posted
August 6, 2007
Last Updated
April 2, 2014
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00513435
Brief Title
Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Official Title
A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (enzyme inhibitor therapy)
Arm Type
Experimental
Arm 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 Type
Drug
Intervention Name(s)
saracatinib
Other Intervention Name(s)
AZD0530
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Response was determined as inicated in the protocol.
Time Frame
From the start of treatment for up to 12 weeks
Secondary Outcome Measure Information:
Title
Overall Survival
Description
The Kaplan-Meier method will be used to estimate overall survival.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Fury
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs