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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00460265
• Date of registration: 12/04/2007
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer SPECTRUM
• Scientific 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)
• Date of first enrolment: May 2007
• Target sample size: 658
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00460265
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Singapore, Sweden, Switzerland, Ukraine, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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])



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Recurrent and/or Metastatic Head and Neck Cancer

Intervention(s)

Drug: ARM 1

Drug: ARM 2

Primary Outcome(s)

Overall Survival [Time Frame: Upto 56 months]

Secondary Outcome(s)

Time to Response [Time Frame: Every 6 weeks until disease progression, upto 56 months]

Overall Response Rate [Time Frame: Every 6 weeks until disease progression, up to 56 months]

Duration of Response [Time Frame: Every 6 weeks until disease progression, up to 56 months]

Progression Free Survival [Time Frame: Every 6 weeks until disease progression or deaths, upto 56 months]

Time to Progression [Time Frame: Every 6 weeks until disease progression, up to 56 months]

Secondary ID(s)

20050251

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00460265