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 22, 2014
Last verified: July 2014

March 29, 2007
July 22, 2014
January 2007
August 2012   (final data collection date for primary outcome measure)
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.
To estimate the effect of panitumumab on progression free survival (PFS) when added to combination chemotherapy in first-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN)
Complete list of historical versions of study NCT00454779 on ClinicalTrials.gov Archive Site
  • 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
  • To estimate the effect of panitumumab on the following endpoints when added to combination chemotherapy in first-line treatment of metastatic or recurrent SCCHN: Overall response rate (ORR)
  • To estimate: Rate of disease control
  • To estimate: Duration of response
  • To estimate: Time to response
  • To estimate: Overall survival (OS)
  • To describe the safety of panitumumab when added to combination chemotherapy
  • To describe PFS, ORR, rate of disease control, duration of response, time to response and OS for second-line panitumumab monotherapy
Not Provided
Not Provided
 
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
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…

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
  • Drug: Cisplatin
    chemotherapy arm
  • Drug: Panitumumab
    experimental arm
  • Drug: Docetaxel
    chemotherapy arm
  • Drug: Cisplatin
    experimental arm
  • Drug: Docetaxel
    experimental arm
  • Experimental: Arm 1
    Panitumumab + Docetaxel + Cisplatin
    Interventions:
    • Drug: Panitumumab
    • Drug: Cisplatin
    • Drug: Docetaxel
  • Arm 2
    control
    Interventions:
    • Drug: Cisplatin
    • Drug: Docetaxel
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
113
September 2014
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Czech Republic,   France,   Lithuania,   Puerto Rico,   Slovakia,   Spain
 
NCT00454779
20050236
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP