PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00446446
First received: March 8, 2007
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

This is an open-label, single-arm, phase 2, multi-center, clinical trial of panitumumab monotherapy for second-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN) subjects. This study will be conducted in North America. Approximately 50 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN will be enrolled into the trial.


Condition Intervention Phase
Cancer
Carcinoma
Head and Neck Cancer
Metastases
Metastatic Cancer
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Oncology
Squamous Cell Carcinoma
Tumors
Drug: Panitumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To estimate the effect of second-line panitumumab monotherapy on objective response rate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Rate of disease control [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Exploratory [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: May 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: panitumumab
Single Arm Monotherapy Study
Drug: Panitumumab
Single Arm Monotherapy Study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using CT or MRI scan
  • Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
  • Karnofsky Performance Status (KPS) score ≥ 60% at screening
  • Men or women age ≥18 years
  • Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test

Exclusion Criteria:

  • Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
  • Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
  • Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
  • History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
  • Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
  • Known allergy or hypersensitivity to any component of panitumumab
  • Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions: - Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed > 24 weeks prior to randomization
  • Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
  • Significant thromboembolic event ≤ 8 weeks prior to enrollment
  • Subjects not recovered from all previous acute radiotherapy-related toxicities
  • History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
  • History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
  • Subject is currently in a clinical trial ≤ 30 days prior to enrollment
  • Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
  • Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
  • Female subject who is pregnant or breast-feeding
  • Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446446

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00446446     History of Changes
Other Study ID Numbers: 20062088
Study First Received: March 8, 2007
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014