Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Recurrence

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Panitumumab

Antineoplastic Agents, Immunological

articipants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.

Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.

To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).

PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Assessments are based on investigator's review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.

Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed.

Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method.

PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions.

Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy.

SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.

Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method.

PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment.

PFS was analyzed using the Kaplan-Meier method.

Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first).

The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug.

Amgen

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.

Age, Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Other

Race/Ethnicity, Customized

Oropharynx

Hypopharynx

Larynx

Oral Cavity

Primary Tumor Site

Locally recurrent disease without metastases

Metastatic

Cancer Stage of Diagnosis

Prior chemotherapy

Prior radiotherapy

Prior surgery

Participants may have received more than one prior treatment.

Prior Treatment for Head and neck Cancer

0 = (Fully Active)

1 = (Restrictive but Ambulatory)

2 = (Ambulatory unable to Work)

A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction;

1. = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
2. = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about \> 50% of waking hours;
3. = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours;
4. = Completely disabled, confined to bed or chair;
5. = Dead.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Study Director

Full analysis set (all enrolled participants who received at least 1 dose of panitumumab) with measurable disease at Baseline

Objective Response Rate

Full analysis set participants with objective responses

Time to Response

Full analysis set participants with an objective response

Duration of Response

Full analysis set with measurable disease at Baseline

Rate of Disease Control

Time to Progression

Progression Free Survival (PFS)

Overall Survival (OS)

Any adverse event

Worst grade of 3

Worst grade of 4

Worst grade of 5

Serious adverse event

Leading to discontinuation of panitumumab

Leading to removal from study

Treatment-related adverse event

Treatment-related worst grade of 3

Treatment-related worst grade of 4

Treatment-related worst grade of 5

Serious treatment-related adverse event

TRAE leading to discontinuation of panitumumab

Treatment-related leading to removal from study

Safety analysis set (all enrolled participants who received at least 1 dose of panitumumab)

Number of Participants With Adverse Events

Overall Study

Rare Diseases

Disease Attributes

Oculocerebral Syndrome With Hypopigmentation

Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

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.

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…

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.

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.

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.

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 from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)

Time from the date of randomization to the date of death during the entire study

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.

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 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 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 from the first dose of panitumumab monotherapy to the date of death during the entire study

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Panitumumab + Docetaxel + Cisplatin, experiment

Panitumumab Plus Chemotherapy

Chemotherapy Alone

Total

All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)

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

all randomized subjects \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review

Overall Response Rate (ORR) During the First-line Treatment Phase

Rate of Disease Control (RDC) During the First-line Treatment Phase

All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response

Duration of Response (DOR) During the First-line Treatment Phase

Time to Response (TTR) During the First-line Treatment Phase

Overall Survival (OS) for the First-line Treatment

Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy

Progression Free Survival (PFS) During the Second-line Treatment Phase

Overall Response Rate (ORR) During the Second-line Treatment Phase

Rate of Disease Control (RDC) During the Second-line Treatment Phase

Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)	NCT00446446	Cancer Carcinoma Head and Neck C... Metastases Metastatic Canc... Metastatic or R... Oncology Squamous Cell C... Tumors	Panitumumab	18 Years -	Amgen
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)	NCT00446446	Cancer Carcinoma Head and Neck C... Metastases Metastatic Canc... Metastatic or R... Oncology Squamous Cell C... Tumors	Panitumumab	18 Years -	Amgen
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response	NCT00454779	Metastatic or R...	Cisplatin Panitumumab Docetaxel Cisplatin Docetaxel	18 Years - 70 Years	Amgen

Spots Global Cancer Trial Database for metastatic or recurrent squamous cell carcinoma of head and neck