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

Phase 2

Completed

Conditions: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Panitumumab
Drug: Cisplatin
Drug: Docetaxel

Registration Number: NCT00454779

Lead Sponsor: Amgen

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 113

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Cisplatin	Panitumumab + Docetaxel + Cisplatin
Arm 2	Docetaxel	control
Arm 2	Cisplatin	control
Arm 1	Docetaxel	Panitumumab + Docetaxel + Cisplatin
Arm 1	Panitumumab	Panitumumab + Docetaxel + Cisplatin

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) During the First-line Treatment Phase	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

Name	Time	Method
Overall Response Rate (ORR) During the First-line Treatment Phase	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.
Progression Free Survival (PFS) During the Second-line Treatment Phase	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.
Time to Response (TTR) During the Second-line Treatment Phase	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)
Overall Survival (OS) for the Second-line Treatment	Until death, up to 57 months	Time from the first dose of panitumumab monotherapy to the date of death during the entire study
Rate of Disease Control (RDC) During the First-line Treatment Phase	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.
Duration of Response (DOR) During the First-line Treatment Phase	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.
Time to Response (TTR) During the First-line Treatment Phase	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)
Overall Survival (OS) for the First-line Treatment	Until death, up to 67 months	Time from the date of randomization to the date of death during the entire study
Duration of Response (DOR) During the Second-line Treatment Phase	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.
Overall Response Rate (ORR) During the Second-line Treatment Phase	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.
Rate of Disease Control (RDC) During the Second-line Treatment Phase	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.