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: July 14, 2014
Last verified: July 2014
  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:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression Free Survival (PFS) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ] [ Designated as safety issue: No ]
    The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.


Secondary Outcome Measures:
  • Overall Response Rate (ORR) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ] [ Designated as safety issue: No ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.

  • Rate of Disease Control (RDC) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ] [ Designated as safety issue: No ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.

  • Duration of Response (DOR) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ] [ Designated as safety issue: No ]
    Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

  • Time to Response (TTR) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ] [ Designated as safety issue: No ]
    Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)

  • Overall Survival (OS) for the First-line Treatment [ Time Frame: Until death, up to 67 months ] [ Designated as safety issue: No ]
    Time from the date of randomization to the date of death during the entire study

  • Progression Free Survival (PFS) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ] [ Designated as safety issue: No ]
    The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.

  • Overall Response Rate (ORR) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ] [ Designated as safety issue: No ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.

  • Rate of Disease Control (RDC) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ] [ Designated as safety issue: No ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.

  • Duration of Response (DOR) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ] [ Designated as safety issue: No ]
    Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

  • Time to Response (TTR) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ] [ Designated as safety issue: No ]
    Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)

  • Overall Survival (OS) for the Second-line Treatment [ Time Frame: Until death, up to 57 months ] [ Designated as safety issue: No ]
    Time from the first dose of panitumumab monotherapy to the date of death during the entire study


Enrollment: 113
Study Start Date: January 2007
Estimated Study Completion Date: September 2014
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00454779

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

Additional Information:
Publications:
Wirth L. PARTNER: A study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer: the PARTNER trial. Community Oncology;2008;5(Supp 14):1-4

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00454779     History of Changes
Other Study ID Numbers: 20050236
Study First Received: March 29, 2007
Results First Received: October 11, 2013
Last Updated: July 14, 2014
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 July 23, 2014