Study of Addition of Panitumumab to Chemoradiation Therapy in Subjects With Locally Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00500760
First received: July 12, 2007
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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
Head and Neck Cancer
Squamous Cell Carcinoma
Drug: Cisplatin
Radiation: Standard Fractionation Radiotherapy
Drug: Panitumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Local-regional control rate [ Time Frame: at two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exploratory (to investigate potential biomarker development) [ Time Frame: Blood samples for biomarker development will be collected until 60 days post completion of radiotherapy. Archived or fresh paraffin-embedded tumor tissue will be collected at anytime during the study ] [ Designated as safety issue: No ]
  • Progression-free survival, overall survival and duration of local-regional control [ Time Frame: Subjects will be followed for at least 2 years from randomisation until end of study ] [ Designated as safety issue: No ]
  • Local-regional control rate [ Time Frame: at 6 months and 1 year ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: by 6 months ] [ Designated as safety issue: No ]
  • Complete response rate [ Time Frame: by 6 months ] [ Designated as safety issue: No ]
  • Safety and Quality of Life [ Time Frame: Subjects will be followed for at least 2 years from randomisation until end of study ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: October 2007
Study Completion Date: November 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 2 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
Active Comparator: Arm 1 Drug: Cisplatin
100 mg/m2 administered IV (in a vein) on days 1, 22 and 43 of radiotherapy
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
  • ECOG performance status of 0 or 1 (you must be well enough to receive chemoradiation therapy)
  • You must be at least 18 years of age
  • Your test results must show that your kidneys, liver and blood cells are working adequately and that, if you are female, you are not pregnant
  • You must have measurable disease

Exclusion Criteria:

  • Cancer of the nasopharynx, sinus, salivary gland or skin
  • History of another cancer (other than head and neck) unless treated with curative intent and with no evidence of disease for more than 3 years, with the exception of non-melanoma skin cancer or in situ cervical cancer
  • Previous treatment with anti-EGFr antibody therapy or EGFr inhibitors
  • Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal sampling or biopsy) or radiotherapy
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within one year before you join the study
  • Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation) resulting in hospitalization within 6 months of study screening
  • History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis)
  • Major surgery within 28 days of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500760

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00500760     History of Changes
Other Study ID Numbers: 20062080
Study First Received: July 12, 2007
Last Updated: December 13, 2011
Health Authority: Finland: Lääkelaitos
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Canada: Health Canada
Hong Kong: Department of Health
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

Keywords provided by Amgen:
Head and Neck Cancer
panitumumab

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014