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

Study Overview
=================
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.

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…

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

Intervention / Treatment
-----------------
* Drug: Cisplatin
* Drug: Panitumumab
* Drug: Docetaxel
* Drug: Cisplatin
* Drug: Docetaxel


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Panitumumab + Docetaxel + Cisplatin | Drug: Panitumumab<br>* experimental arm<br>Drug: Cisplatin<br>* experimental arm<br>Drug: Docetaxel<br>* experimental arm<br>|
| Other: Arm 2<br>control | Drug: Cisplatin<br>* chemotherapy arm<br>Drug: Docetaxel<br>* chemotherapy arm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) During the First-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 67 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) During the First-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 67 months | 
| Rate of Disease Control (RDC) During the First-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 67 months | 
| Duration of Response (DOR) During the First-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 67 months | 
| Time to Response (TTR) During the First-line Treatment Phase | Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter) | Every 6 weeks until disease progression or death, up to 67 months | 
| Overall Survival (OS) for the First-line Treatment | Time from the date of randomization to the date of death during the entire study | Until death, up to 67 months | 
| Progression Free Survival (PFS) During the Second-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 57 months | 
| Overall Response Rate (ORR) During the Second-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 57 months | 
| Rate of Disease Control (RDC) During the Second-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 57 months | 
| Duration of Response (DOR) During the Second-line Treatment Phase | 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. | Every 6 weeks until disease progression or death, up to 57 months | 
| Time to Response (TTR) During the Second-line Treatment Phase | 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) | Every 6 weeks until disease progression or death, up to 57 months | 
| Overall Survival (OS) for the Second-line Treatment | Time from the first dose of panitumumab monotherapy to the date of death during the entire study | Until death, up to 57 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCCHNC, Metastatic, Recurrent