Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer

NCT00460265 | Completed Phase 3 Results DMC

• 1 other identifier: 20050251
• Study Type: interventional
• Target: 658
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.

Conditions

Recurrent and/or Metastatic Head and Neck Cancer

Keywords

Squamous Cell Carcinoma; Epidermal Growth Factor; Epidermal Growth Factor Receptor; SCCHN; Metastatic Head and Neck Cancer; EGFr; Head and Neck Cancer; Recurrent Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from randomization to death

  Upto 56 months

Secondary Outcomes (5)

• Overall Response Rate

  Every 6 weeks until disease progression, up to 56 months

• Duration of Response

  Every 6 weeks until disease progression, up to 56 months

• Time to Progression

  Every 6 weeks until disease progression, up to 56 months

• Time to Response

  Every 6 weeks until disease progression, upto 56 months

• Progression Free Survival

  Every 6 weeks until disease progression or deaths, upto 56 months

Study Arms (2)

ARM 2

ACTIVE COMPARATOR

Arm 2 consists of Cisplatin and 5-FU

Drug: ARM 2

ARM 1

EXPERIMENTAL

ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU

Drug: ARM 1

Interventions

ARM 2 DRUG

Subjects will receive Cisplatin plus 5FU

ARM 2

ARM 1 DRUG

Subjects will receive Panitumumab plus cisplatin and 5FU

ARM 1

Eligibility Criteria

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

You may qualify if:

• Man or woman at least 18 years old.
• Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
• Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
• Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
• Measurable and non-measurable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• History or known presence of Central Nervous System (CNS) metastases.
• History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
• Nasopharyngeal carcinoma.
• Prior systemic treatment for metastatic and/or recurrent SCCHN
• Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
• Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
• Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
• Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing \[without monitoring program\])

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521;

  BACKGROUND

• Vermorken JB, Stohlmacher-Williams J, Davidenko I, Licitra L, Winquist E, Villanueva C, Foa P, Rottey S, Skladowski K, Tahara M, Pai VR, Faivre S, Blajman CR, Forastiere AA, Stein BN, Oliner KS, Pan Z, Bach BA; SPECTRUM investigators. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697-710. doi: 10.1016/S1470-2045(13)70181-5. Epub 2013 Jun 6.

  PMID: 23746666 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

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

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2007
• First Posted: April 13, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2012
• Last Updated: March 7, 2014
• Results First Posted: June 14, 2011

Record last verified: 2014-02