Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00547157
First received: October 18, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.


Condition Intervention Phase
Cancer
Head and Neck Cancer
Oncology
Squamous Cell Carcinoma
Drug: Panitumumab
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Local Regional Control Rate at 2 Years [ Time Frame: from study day 1 to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator's assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).


Secondary Outcome Measures:
  • Duration of Local Regional Control [ Time Frame: maximum follow up time 46.2 months ] [ Designated as safety issue: No ]
    Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)

  • Progression-free Survival [ Time Frame: maximum follow up time 46.2 months ] [ Designated as safety issue: No ]
    Time from first dose date till disease progression or death

  • Overall Survival [ Time Frame: maximum follow up time 46.2 months ] [ Designated as safety issue: No ]
    Time from first dose date to death

  • ORR by 6 Months - Central [ Time Frame: From randomization to 6 months ] [ Designated as safety issue: No ]
    ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.

  • CRR by 6 Months - Central [ Time Frame: From randomization till 6 months ] [ Designated as safety issue: No ]
    CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.


Enrollment: 152
Study Start Date: November 2007
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARM 1 CRT
Cisplatin plus RT
Drug: Cisplatin
Cisplatin
Other Name: Cisplatin (Chemotherapy)
Experimental: ARM 2 PRT
Panitumumab plus RT
Drug: Panitumumab
Arm 2 consists of panitmumab plus RT
Other Name: Panitumumab (drug)

Detailed Description:

Primary Objective: To estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN).

Secondary Objectives: To estimate the difference between 2 treatment regimens (CRT vs PRT) on other measures of clinical benefit, including LRC, overall response rate (ORR), progression-free survival (PFS), overall survival (OS); and safety.

Tertiary Objectives: To estimate the difference in health-related quality of life (HRQoL) and performance status in subjects receiving PRT or CRT.

Exploratory Objectives: To investigate potential biomarker development based on assessment of blood and tumor and the proposed mechanism of actions of study drugs. In addition, to investigate the effect of genetic variation in cancer genes and drug target genes on SCCHN and subject response to study drugs (separate informed consent required).

Hypothesis: A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.

Study Design: This is a phase 2, open-label, randomized, multicenter study. Eligible subjects will be randomized in a 2:3 ratio to either of the following regimens:

Arm 1 CRT:

  • Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
  • Cisplatin: 100 mg/m2 (given on days 1 and 22 of RT) or

Arm 2 PRT:

  • Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
  • Panitumumab: 9.0 mg/kg Q3W (given on days 1, 22, and 43 of RT)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1 Bidimensionally measurable disease >/= 10 mm in at least 1 dimension

Exclusion Criteria:

NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for >/= 3 years NO Prior treatment for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) NO Major surgery </= 28 days before randomization or minor surgery </= 14 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547157

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00547157     History of Changes
Other Study ID Numbers: 20062079, CONCERT2
Study First Received: October 18, 2007
Results First Received: December 16, 2013
Last Updated: July 10, 2014
Health Authority: Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Mexico: COFEPRIS
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
head and neck
squamous cell carcinoma
radiotherapy
chemoradiotherapy
panitumumab
locally advanced head & neck cancer
EGFr
epidermal growth factor receptor
SCCHN
locally advanced SCCHN
HNC
epidermal growth factor

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on July 23, 2014