Clinical trial NCT00460265: Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Official title: A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-04-13
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 \[without monitoring program\])

Primary outcomes:
measure: Overall Survival
timeFrame: Upto 56 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Every 6 weeks until disease progression, up to 56 months
measure: Duration of Response
timeFrame: Every 6 weeks until disease progression, up to 56 months
measure: Time to Progression
timeFrame: Every 6 weeks until disease progression, up to 56 months
measure: Time to Response
timeFrame: Every 6 weeks until disease progression, upto 56 months
measure: Progression Free Survival
timeFrame: Every 6 weeks until disease progression or deaths, upto 56 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521;
citation: 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.