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

Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck Clinical Trial

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…

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454779
• Other study ID #: 20050236
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2007
• Est. completion date: January 1, 2014

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 1, 2014
• Est. primary completion date: June 11, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Cisplatin
chemotherapy arm
• Panitumumab
experimental arm
• Docetaxel
chemotherapy arm
• Cisplatin
experimental arm
• Docetaxel
experimental arm

Locations

Country	Name	City	State
Austria	Research Site	Graz
Austria	Research Site	Leoben
Austria	Research Site	Linz
Austria	Research Site	Wien
Belgium	Research Site	Brasschaat
Belgium	Research Site	Brugge
Belgium	Research Site	Kortrijk
Belgium	Research Site	Libramont
Belgium	Research Site	Liege
Belgium	Research Site	Ottignies
Belgium	Research Site	Wilrijk
Czechia	Research Site	Brno
Czechia	Research Site	Praha 5
Czechia	Research Site	Znojmo
France	Research Site	Angers
France	Research Site	Lens cedex
France	Research Site	Perpignan
France	Research Site	Vandoeuvre les Nancy
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Vilnius
Puerto Rico	Research Site	San Juan
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Nove Zamky
Slovakia	Research Site	Presov
Slovakia	Research Site	Spisska Nova Ves
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Girona	Cataluña
Spain	Research Site	L Hospitalet De Llobregat	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Valencia	Comunidad Valenciana
United States	Research Site	Abingdon	Virginia
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Arlington	Texas
United States	Research Site	Ashland	Kentucky
United States	Research Site	Athens	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Billings	Montana
United States	Research Site	Binghamton	New York
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Bronx	New York
United States	Research Site	Canton	Ohio
United States	Research Site	Centralia	Illinois
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	Missouri
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Duarte	California
United States	Research Site	Elk Grove Village	Illinois
United States	Research Site	Evanston	Illinois
United States	Research Site	Frederick	Maryland
United States	Research Site	Galveston	Texas
United States	Research Site	Greenville	South Carolina
United States	Research Site	Griffin	Georgia
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Henderson	Nevada
United States	Research Site	Jefferson City	Missouri
United States	Research Site	Jonesboro	Arkansas
United States	Research Site	La Jolla	California
United States	Research Site	La Verne	California
United States	Research Site	Lakeland	Florida
United States	Research Site	Langhorne	Pennsylvania
United States	Research Site	Lansing	Michigan
United States	Research Site	Lexington	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Louisville	Kentucky
United States	Research Site	Madison	Wisconsin
United States	Research Site	Marietta	Georgia
United States	Research Site	Marshfield	Wisconsin
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Mineola	New York
United States	Research Site	Morgantown	West Virginia
United States	Research Site	New Port Richey	Florida
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Norwich	Connecticut
United States	Research Site	Nyack	New York
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Paducah	Kentucky
United States	Research Site	Park Ridge	Illinois
United States	Research Site	Pascagoula	Mississippi
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Rochester	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Cruz	California
United States	Research Site	Scranton	Pennsylvania
United States	Research Site	Syracuse	New York
United States	Research Site	Toledo	Ohio
United States	Research Site	Tucson	Arizona
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Wichita	Kansas
United States	Research Site	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  France,  Lithuania,  Puerto Rico,  Slovakia,  Spain, 

References & Publications (1)

Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   AmgenTrials clinical trials website