Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Phase 2

Completed

• Conditions: Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Larynx
• Interventions: Drug: sunitinib malate

• Registration Number: NCT00387335
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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

Detailed Description

OBJECTIVES:

I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate.

II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B).

OUTLINE: This is a multicenter, cohort study.

Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 \[cohort A\] vs ECOG 2 \[cohort B\]). Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 1 year.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-12
• Results First Submitted: 2013-12-04
• Results First Submitted QC: 2013-12-04
• Results First Posted: 2014-01-22
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	sunitinib malate	Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Feasibility of Treatment	While patient remains on treatment, up to 30 weeks	Ability to remain on treatment without dose reduction
Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria	While patient remains on treatment, up to 30 weeks	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Up to 2 years	Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival	Up to two years	Time from start of treatment until death from any cause.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States