Trials / Completed
CompletedNCT01466244
Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397
PTEN Determination in Squamous Cell Cancer of The Head and Neck Treated on E5397, A Randomized Phase III Trial of Cisplatin Plus Placebo Versus Cisplatin Plus C225 (Cetuximab) in Metastatic/Recurrent Head and Neck Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 42 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.
Detailed description
OBJECTIVES: Primary * Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers. Secondary * Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient and PTEN-expressing cancers, by treatment arm. OUTLINE: Tissue microarray slides collected earlier from ECOG-E5397 are immunostained with PTEN antibody and analyzed with AQUA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | cetuximab | |
| DRUG | cisplatin | |
| GENETIC | gene expression analysis | |
| GENETIC | microarray analysis | |
| OTHER | immunohistochemistry staining method | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2011-11-11
- Primary completion
- 2012-01-11
- Completion
- 2012-01-11
- First posted
- 2011-11-07
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT01466244. Inclusion in this directory is not an endorsement.