Biomarkers in Patients With Head and Neck Cancer
This study is not yet open for participant recruitment.
Verified November 2011 by National Cancer Institute (NCI)
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01466257
First received: November 2, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
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Purpose
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Biological: cetuximab Drug: cisplatin Genetic: DNA analysis Genetic: gene expression analysis Genetic: mutation analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Mutation rates of HRAS and PIK3CA [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.
- To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.
OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Treated on protocol ECOG-E5397
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01466257 History of Changes |
| Other Study ID Numbers: | CDR0000715520, ECOG-E5397T2 |
| Study First Received: | November 2, 2011 |
| Last Updated: | November 2, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal 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 oropharynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the hypopharynx |
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 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 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 untreated metastatic squamous neck cancer with occult primary |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
Cetuximab Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013