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

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ClinicalTrials.gov Identifier: NCT00454779
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : February 7, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck Drug: Cisplatin Drug: Panitumumab Drug: Docetaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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…
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : June 11, 2012
Actual Study Completion Date : January 1, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]
    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 :
  1. Overall Response Rate (ORR) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]
    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.

  2. 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 ]
    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.

  3. Duration of Response (DOR) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]
    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.

  4. Time to Response (TTR) During the First-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 67 months ]
    Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)

  5. Overall Survival (OS) for the First-line Treatment [ Time Frame: Until death, up to 67 months ]
    Time from the date of randomization to the date of death during the entire study

  6. Progression Free Survival (PFS) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]
    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.

  7. Overall Response Rate (ORR) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]
    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.

  8. 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 ]
    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.

  9. Duration of Response (DOR) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]
    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.

  10. Time to Response (TTR) During the Second-line Treatment Phase [ Time Frame: Every 6 weeks until disease progression or death, up to 57 months ]
    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)

  11. Overall Survival (OS) for the Second-line Treatment [ Time Frame: Until death, up to 57 months ]
    Time from the first dose of panitumumab monotherapy to the date of death during the entire study


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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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): NCT00454779


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

Publications:
Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00454779    
Other Study ID Numbers: 20050236
First Posted: April 2, 2007    Key Record Dates
Results First Posted: February 7, 2014
Last Update Posted: October 17, 2018
Last Verified: September 2018
Keywords provided by Amgen:
SCCHNC
Metastatic
Recurrent
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Cisplatin
 Docetaxel
Panitumumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological