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Completed

NCT Number: NCT00454779

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

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.

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Key information

Conditions

Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck Disease Attributes Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

chemotherapy arm

Panitumumab

Drug

experimental arm

docetaxel

Drug

chemotherapy arm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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…

Important dates

Study start
2007
Primary completion
2012
Study completion
2014
First posted
Apr 2, 2007
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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