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Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer (S10PANI01)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643056
First Posted: December 30, 2015
Last Update Posted: December 30, 2015
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.
Collaborator:
Clinical Trial Unit Ente Ospedaliero Cantonale (CTU-EOC)
Information provided by (Responsible Party):
Tatiana Terrot, Oncology Institute of Southern Switzerland
  Purpose

Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety profile of panitumumab in patients affected by Head and Neck cancer after at least one cisplatin or carboplatin-based chemotherapy. A translational research study is also planned to evaluate EGFR status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and HPV genotyping by reverse hybridization.

Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive disease, unacceptable toxicity, pregnancy, or patient's refusal


Condition Intervention Phase
Advanced Head and Neck Squamous Cancer Drug: Panitumumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cance

Resource links provided by NLM:


Further study details as provided by Tatiana Terrot, Oncology Institute of Southern Switzerland:

Primary Outcome Measures:
  • Rate of tumor response in advanced platinum-resistant head and neck cancer [ Time Frame: Radiological tumor evaluation every 8 weeks, minimum 12 weeks ]
    To evaluate rate of radiological tumor response in advanced platinum-resistant head and neck cancer


Secondary Outcome Measures:
  • Adverse Event according to CTCAE v.3 [ Time Frame: Collection of adverse event for at least the first 8 weeks ]
    To collect all adverse event occurred during the treatment

  • Analysis of tumor biomarkers [ Time Frame: 28 days (1 cycle) ]
    To identify the tumor biomarkers that can best predict response to panitumumab


Enrollment: 32
Study Start Date: January 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab
6 mg/kg per administration
Drug: Panitumumab
IV administration every 2 weeks

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG performance status 0-2, not pregnant.
  • Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation.
  • Baseline tumor tissue, sufficient material available for EGFR determination (therapeutic target of panitumumab) and biomarker studies. Patients without available tissue at baseline or with tissue collected longer than 1 year before, may undergo tumor biopsy.
  • Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen.
  • Measurable disease (RECIST 1.1).
  • Adequate hematological values, renal and hepatic function.
  • Patients may not be receiving any other investigational agents

Exclusion Criteria:

  • Platinum-naïve patients.
  • Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response.
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization.
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  • Known or suspected brain metastases.
  • Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent
  • Known hypersensitivity to panitumumab active ingredient or excipients.
  • Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - HIV positive patients
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02643056


Sponsors and Collaborators
Southern Europe New Drug Organization
Clinical Trial Unit Ente Ospedaliero Cantonale (CTU-EOC)
Investigators
Study Chair: Michele Ghielmini, Prof Oncology Institute of Southern Switzerland
  More Information

Responsible Party: Tatiana Terrot, Project Manager, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT02643056     History of Changes
Other Study ID Numbers: S10PANI01
First Submitted: December 8, 2015
First Posted: December 30, 2015
Last Update Posted: December 30, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs