Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00798655|
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : August 9, 2016
Last Update Posted : October 3, 2017
The objectives for this study is as follows:
- To evaluate the progression-free survival of locoregionally advanced (stages III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Panitumumab Drug: Cisplatin Radiation: Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer|
|Actual Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||November 9, 2016|
Experimental: Panitumumab, Cisplatin plus radiation
Standard radiation 60-66 Gy with 200 cGy daily fractions in 6-7 weeks Cisplatin* 30 mg/m2 IV, weekly during radiation (total of 6-7 doses based upon radiation therapy dose requirements) Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-7 doses based upon radiation therapy dose requirements)
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
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.
- Probability of Progression-free Survival (PFS) at 2 Years [ Time Frame: Up to 90 months for cohort; individual patients up to 24 months after study treatment ]
- Probability of 2-year Overall Survival [ Time Frame: Up to 90 months for cohort; individual patients up to 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798655
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Robert Ferris, MD||University of Pittsburgh|