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PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00454779
First received: March 29, 2007
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.


Condition Intervention Phase
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
 Drug: Cisplatin
Drug: Panitumumab
Drug: Docetaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression Free Survival (PFS) during the first-line treatment phase [ Time Frame: Until withdrawal of full consent or approximately 24 months after the last subject is randomized, whichever occurs first. ] [ Designated as safety issue: Yes ]
    Progression Free Survival (PFS) during the first-line treatment phase


Secondary Outcome Measures:
  • Overall Response Rate (ORR), rate of disease control, duration of response, time to response, overal survival separately for first-line and second-line treatment phases [ Time Frame: Until withdrawal of full consent or approximately 24 months after the last subject is randomized, whichever occurs first. ] [ Designated as safety issue: Yes ]
    Overall Response Rate (ORR), rate of disease control, duration of response, time to response, overal survival separately for first-line and second-line treatment phases


Enrollment: 110
Study Start Date: January 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Panitumumab + Docetaxel + Cisplatin
 Drug: Panitumumab
experimental arm
Drug: Cisplatin
experimental arm
Drug: Docetaxel
experimental arm
Arm 2
control
 Drug: Cisplatin
chemotherapy arm
Drug: Docetaxel
chemotherapy arm

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
  • Measurable disease by CT scan
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Age: 18 years or older
  • Adequate hematologic, renal, metabolic, hepatic & thyroid function

Exclusion Criteria:

  • Prior systemic treatment for metastatic and/or recurrent SCCHN
  • CNS metastases, or nasopharyngeal carcinoma
  • History of interstitial lung disease
  • History of another primary cancer

  • Any co-morbid disease that would increase risk of toxicity

    • Active infection requiring systemic treatment
    • Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454779

  Show 114 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00454779     History of Changes
Other Study ID Numbers: 20050236
Study First Received: March 29, 2007
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
SCCHNC
Metastatic
Recurrent

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
 Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on May 22, 2013