Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00513435
First received: August 6, 2007
Last updated: August 24, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: saracatinib Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression-free survival [ Time Frame: From the start of treatment for up to 12 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Objective response rate [ Time Frame: At the end of each 6-8 weeks course for up to 12 weeks ] [ Designated as safety issue: No ]Response will be evaluated in this study using the new international criteria proposed by RECIST. A single-stage binomial design we will be able to estimate the frequency of response with a 95% confidence interval of not greater than ± 19.6%. All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) should be included in the main analysis of the response rate.
- Overall survival [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]The Kaplan-Meier method will be used to estimate overall survival.
- Pharmacodynamic effects of AZD0530 on c-Src and downstream signaling molecules STAT3 and STAT5 [ Time Frame: Baseline and days 21-35 of treatment ] [ Designated as safety issue: No ]Descriptive statistics will be used for Western blotting and immunohistochemical studies.
| Enrollment: | 28 |
| Study Start Date: | July 2007 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (enzyme inhibitor therapy)
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.
|
Drug: saracatinib
Given PO
Other Name: AZD0530
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513435
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Matthew Fury | Memorial Sloan-Kettering Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00513435 History of Changes |
| Obsolete Identifiers: | NCT01645618, NCT01664468 |
| Other Study ID Numbers: | NCI-2009-00192, 06-074, CDR0000559632, N01CM62206 |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Respiratory Tract Diseases Otorhinolaryngologic Diseases Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Tongue Diseases Neoplasm Metastasis Neoplastic Processes Pathologic Processes Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Respiratory Tract Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013