Overview

This trial is active, not recruiting.

Condition metastatic or recurrent squamous cell carcinoma of head and neck
Treatments cisplatin, panitumumab, docetaxel
Phase phase 2
Target EGFR
Sponsor Amgen
Start date January 2007
End date August 2012
Trial size 113 participants
Trial identifier NCT00454779, 20050236

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Panitumumab + Docetaxel + Cisplatin
panitumumab
experimental arm
cisplatin
experimental arm
docetaxel
experimental arm
(Other)
control
cisplatin
chemotherapy arm
docetaxel
chemotherapy arm

Primary Outcomes

Measure
Progression Free Survival (PFS) During the First-line Treatment Phase
time frame: Every 6 weeks until disease progression or death, up to 67 months

Secondary Outcomes

Measure
Overall Response Rate (ORR) During the First-line Treatment Phase
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
time frame: Every 6 weeks until disease progression or death, up to 67 months
Duration of Response (DOR) During the First-line Treatment Phase
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 frame: Every 6 weeks until disease progression or death, up to 67 months
Overall Survival (OS) for the First-line Treatment
time frame: Until death, up to 67 months
Progression Free Survival (PFS) 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
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
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 frame: Every 6 weeks until disease progression or death, up to 57 months
Time to Response (TTR) During the Second-line Treatment Phase
time frame: Every 6 weeks until disease progression or death, up to 57 months
Overall Survival (OS) for the Second-line Treatment
time frame: Until death, up to 57 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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…
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Amgen.