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

NCT00500760 | Completed Phase 2 Results

• 1 other identifier: 20062080
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Cancer; Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; panitumumab

Outcome Measures

Primary Outcomes (1)

• Local Regional Control Rate at 2 Years

  In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.

  2 years

Secondary Outcomes (6)

• Local Regional Control Rate at 6 Months and 12 Months

  6 months and 12 months

• Duration of Local-regional Control

  From first dose up to 37 months

• Progression-Free Survival

  From first dose date to 37 months

• Overall Survival

  From first dose date up to 37 months

• Percentage of Participants With an Objective Response at 6 Months

  6 months

Study Arms (2)

Panitumumab Plus Chemoradiation

EXPERIMENTAL

Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.

Drug: Cisplatin; Radiation: Standard Fractionation Radiotherapy; Drug: Panitumumab

Chemoradiotherapy Alone

ACTIVE COMPARATOR

Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.

Drug: Cisplatin; Radiation: Standard Fractionation Radiotherapy

Interventions

Cisplatin DRUG

Administered intravenously (IV; in a vein)

Chemoradiotherapy Alone; Panitumumab Plus Chemoradiation

Standard Fractionation Radiotherapy RADIATION

70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)

Chemoradiotherapy Alone; Panitumumab Plus Chemoradiation

Panitumumab DRUG

Administered intravenously

Also known as: Vectibix®

Panitumumab Plus Chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
• Eastern Cooperative Oncology Group (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

You may not qualify if:

• 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-endothelial growth factor receptor (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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Mesia R, Henke M, Fortin A, Minn H, Yunes Ancona AC, Cmelak A, Markowitz AB, Hotte SJ, Singh S, Chan AT, Merlano MC, Skladowski K, Zhang A, Oliner KS, VanderWalde A, Giralt J. Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):208-20. doi: 10.1016/S1470-2045(14)71198-2. Epub 2015 Jan 15.

  PMID: 25596660 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Cisplatin; Panitumumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 13, 2007
• Study Start: October 1, 2007
• Primary Completion: March 29, 2011
• Study Completion: April 26, 2011
• Last Updated: October 17, 2018
• Results First Posted: August 5, 2014

Record last verified: 2018-09