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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 12, 2007
First Posted Date  ICMJE April 13, 2007
Results First Submitted Date  ICMJE May 13, 2011
Results First Posted Date  ICMJE June 14, 2011
Last Update Posted Date March 7, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2011)
Overall Survival [ Time Frame: Upto 56 months ]
Time from randomization to death
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2007)
Overall Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2011)
  • 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.
  • 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).
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2007)
  • Progression free survival
  • Overall response rate
  • Duration of response
  • Time to progression
  • Safety
  • Evaluate time to response
  • Patient reported outcomes
  • Exploratory Objective: To investigate potential biomarker development
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent and/or Metastatic Head and Neck Cancer
Intervention  ICMJE
  • Drug: ARM 2
    Subjects will receive Cisplatin plus 5FU
  • Drug: ARM 1
    Subjects will receive Panitumumab plus cisplatin and 5FU
Study Arms  ICMJE
  • Active Comparator: ARM 2
    Arm 2 consists of Cisplatin and 5-FU
    Intervention: Drug: ARM 2
  • Experimental: ARM 1
    ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU
    Intervention: Drug: ARM 1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2009)
658
Original Enrollment  ICMJE
 (submitted: April 12, 2007)
650
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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])
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries 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
 
Administrative Information
NCT Number  ICMJE NCT00460265
Other Study ID Numbers  ICMJE 20050251
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP