Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Nasopharyngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • 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

NCT number NCT00513435
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date July 2007
Completion date March 2011

See also
  Status Clinical Trial Phase
Completed NCT01469429 - Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer. Phase 1/Phase 2
Withdrawn NCT04041141 - Oral Stent Device for Radiation Treatments of Oral Cancers
Completed NCT00049283 - Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer Phase 1
Completed NCT00407810 - Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00096512 - S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT01637194 - Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer Phase 1
Completed NCT00033618 - Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck Phase 2
Completed NCT01816841 - Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care N/A
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Completed NCT04059861 - Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin N/A
Recruiting NCT01854021 - Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer N/A
Completed NCT01816984 - PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT01674374 - Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy Phase 2
Terminated NCT01528137 - Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer Phase 1
Completed NCT04337853 - Radiotherapy of Tongue Cancer Using an Intraoral Stent Phase 1
Completed NCT01806675 - 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy Phase 1/Phase 2
Active, not recruiting NCT01847326 - Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer Phase 1
Terminated NCT02177838 - Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer N/A
Completed NCT00114283 - Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Phase 2
Completed NCT04126226 - Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy N/A