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

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ClinicalTrials.gov Identifier: NCT00460265
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : June 14, 2011
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent and/or Metastatic Head and Neck Cancer Drug: ARM 2 Drug: ARM 1 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ARM 2
Arm 2 consists of Cisplatin and 5-FU
 Drug: ARM 2
Subjects will receive Cisplatin plus 5FU
Experimental: ARM 1
ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU
 Drug: ARM 1
Subjects will receive Panitumumab plus cisplatin and 5FU


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Upto 56 months ]
    Time from randomization to death


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Every 6 weeks until disease progression, up to 56 months ]
    An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.

  2. Duration of Response [ Time Frame: Every 6 weeks until disease progression, up to 56 months ]
    Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).

  3. Time to Progression [ Time Frame: Every 6 weeks until disease progression, up to 56 months ]
    Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)

  4. Time to Response [ Time Frame: Every 6 weeks until disease progression, upto 56 months ]
    Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.

  5. Progression Free Survival [ Time Frame: Every 6 weeks until disease progression or deaths, upto 56 months ]
    Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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])
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460265


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00460265     History of Changes
Other Study ID Numbers: 20050251
First Posted: April 13, 2007    Key Record Dates
Results First Posted: June 14, 2011
Last Update Posted: March 7, 2014
Last Verified: February 2014

Keywords provided by Amgen:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
 Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs