Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer

Summary

The objectives for this study is as follows:

* Primary:

* To evaluate the progression-free survival of locoregionally advanced (stages III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab.
* Secondary:

* To evaluate the overall survival, event-free survival, and toxicities.
* To correlate efficacy parameters with 1) EGFR and downstream pathway activation, 2) FcyR polymorphisms, and 3) serum cytokine profiles. More specifically, the aim is to demonstrate the usefulness of biomarkers (downstream signaling molecules, FcyR polymorphisms, or tumor and serum cytokine(s) in predicting progression-free survival in patients with SCCHN treated with the above treatment. Specific biomarkers that relate to Epidermal Growth Factor Receptor and angiogenesis, including EGFR, pEGFR, Src, pMAPK, pSTAT3, pSTAT5, pSTAT1, pAKT, p38, p21, p27, PARP, E-cadherin, p-ErbB3, Ki67, VEGF, and IL-8, using reverse phase protein microarrays (RPPA) will be tested in baseline archival paraffin-embedded tumor tissue. To collect tumor tissue from pretreatment biopsies for cytokine/chemokine and immune biomarker studies on tumor tissue. We plan to investigate the expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers. In addition, EGFR polymorphisms will be studied in tumor tissue samples and serum. Additional studies may be performed in the future. Some of these studies may be performed by Amgen.

Conditions

• Cancer of Head
• Cancer of Head and Neck
• Cancer of Neck
• Cancer of the Head
• Cancer of the Head and Neck
• Cancer of the Neck
• Head and Neck Cancer
• Head Cancer
• Head Neoplasms
• Head, Neck Neoplasms
• Neck Cancer
• Neck Neoplasms
• Neoplasms, Head
• Neoplasms, Head and Neck
• Neoplasms, Neck
• Neoplasms, Upper Aerodigestive Tract
• UADT Neoplasms
• Upper Aerodigestive Tract Neoplasms

Interventions

DRUG

Panitumumab

Panitumumab, starting dose, 2.5mg/kg will be given as an intravenous infusion (IV) through a vein in your arm, once a week before radiation and chemotherapy for 6 weeks; treatment takes about an hour. The panitumumab dose will be calculated based on the subject's actual weekly body weight

DRUG

Cisplatin

Cisplatin, 30 mg/m2 will be given as an intravenous infusion (IV) through a vein in your arm, once a week before radiation therapy and after panitumumab for 6 weeks; treatment takes about an hour

RADIATION

Radiation Therapy

Radiation Therapy 60-66 Gy/200 cGy/daily, five days a week, Monday through Friday, except on weekends and holidays, for six weeks; treatments take about 20 minutes. Radiation will be administered either prior to chemo treatment or after chemo treatment as long as radiation is given on the same day.

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• Robert Ferris

  lead OTHER

Principal Investigators

• Robert Ferris, MD · University of Pittsburgh

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2015-06-30

Completion

2016-11-09

Countries

• United States

Study Locations