Blood Proteins in Predicting Treatment Benefit in Patient... | NCT00896675

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2013

Last Update Posted Date

Apr 2, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Studying samples of blood in the laboratory may help doctors learn more about cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at proteins in blood samples to predict treatment benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.

Detailed Description

OBJECTIVES:

To identify head and neck squamous cell cancer patients who will benefit from treatment with the EGFR inhibitors (i.e., erlotinib hydrochloride, gefitinib, and cetuximab) and VEGF inhibitor (i.e., bevacizumab), based on predictive proteomic profiles in patient blood samples.

OUTLINE: This is a multicenter study.

Blood samples are analyzed for proteomic profile to determine good and bad prognoses in patients treated with or without EGFR inhibitors and/or a VEGF inhibitor.

Conditions Module

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

352Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients treated with EGFR inhibitors and/or VEGF inhibitor			Other: proteomic profiles
NOT treated with EGFR inhibitors and/or VEGF inhibitor			Other: proteomic profiles

Interventions

Name	Type	Description	Arm Group Labels	Other Names
proteomic profiles	Other	blood samples analysis	patients treated with EGFR inhibitors and/or VEGF inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of patients who will benefit from treatment with EGFR and/or VEGF inhibitors based on serum proteomic profiles		upon analysis of each patient tissue collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of squamous cell head and neck cancer
- Recurrent and/or metastatic disease
Meets 1 of the following criteria:
- Previously treated with EGFR inhibitors and/or VEGF inhibitor on 1 of the following clinical trials, and has available blood samples:
  - A Phase I/II Study of Bevacizumab (rhu MAb VEGF) in Combination With OSI-774 for Patients With Recurrent or Metastatic Cancer of the Head and Neck
  - A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
- Previously treated with cetuximab and has blood samples available from protocol VU-VICC-HN-0356
- Previously treated with conventional chemotherapy and has blood samples available from protocol VU-VICC-HN-0356

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Head and Neck cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Murphy, MD	Vanderbilt-Ingram Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt-Ingram Cancer Center - Cool Springs		Nashville	Tennessee	37064	United States
Vanderbilt-Ingram Cancer Center at Franklin

ID	Type	Link
P30CA068485	U.S. NIH Grant/Contract	View source
VU-VICC-HN-0744
VU-VICC-070359

ID	Term
D006258	Head and Neck Neoplasms
D000077195	Squamous Cell Carcinoma of Head and Neck
D012468	Salivary Gland Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009062	Mouth Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D012466	Salivary Gland Diseases