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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00500760 |
The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.
Condition | Intervention | Phase |
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Head and Neck Cancer Squamous Cell Carcinoma |
Radiation: Standard Fractionation Radiotherapy Drug: Panitumumab Drug: Cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck |
Estimated Enrollment: | 150 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 2: Experimental |
Radiation: Standard Fractionation Radiotherapy
Radiotherapy can be given with 3D or IMRT techniques. 70 Gy will be administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)
Drug: Panitumumab
9 mg/kg administered IV (in the vein) on days 1, 22 and 43 of radiotherapy
Drug: Cisplatin
75 mg/m2 administered IV (in a vein) on days 1, 22 and 43 of radiotherapy
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Arm 1: Active Comparator |
Radiation: Standard Fractionation Radiotherapy
Radiotherapy can be given with 3D or IMRT techniques. 70 Gy will be administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)
Drug: Cisplatin
100 mg/m2 administered IV (in a vein) on days 1, 22 and 43 of radiotherapy
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20062080 |
Study First Received: | July 12, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00500760 |
Health Authority: | Canada: Health Canada; Finland: Lääkelaitos; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; Italy: Local Ethics Committees; Mexico: COFEPRIS; Spain: Agencia Española de Medicamentos y Productos Sanitarios; United States: Food and Drug Administration; Hong Kong: Department of Health |
Head and Neck Cancer panitumumab |
Epidermoid carcinoma Cisplatin Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |