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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
113
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.
Time frame: Every 6 weeks until disease progression or death, up to 67 months
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.
Time frame: 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.
Time frame: Every 6 weeks until disease progression or death, up to 67 months
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experimental arm
experimental arm
Research Site
Tucson, Arizona, United States
Research Site
Jonesboro, Arkansas, United States
Research Site
Duarte, California, United States
Research Site
La Jolla, California, United States
Research Site
La Verne, California, United States
Research Site
Los Angeles, California, United States
Research Site
Santa Cruz, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
Norwich, Connecticut, United States
...and 104 more locations
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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Until death, up to 57 months