Phase 2 N=113 Randomized Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT00454779 ↗

Enrolled (actual)

113

Serious AEs

54.9%

Results posted

Feb 2014

Primary outcome: Primary: Progression Free Survival (PFS) During the First-line Treatment Phase — 6.9; 5.5 Months — p=0.051

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cisplatin (Drug); Panitumumab (Drug); Docetaxel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival (PFS) During the First-line Treatment Phase	6.9; 5.5	0.051
SECONDARY Overall Response Rate (ORR) During the First-line Treatment Phase	44.23; 37.25	—
SECONDARY Rate of Disease Control (RDC) During the First-line Treatment Phase	80.77; 72.55	—
SECONDARY Duration of Response (DOR) During the First-line Treatment Phase	8.0; 5.1	—
SECONDARY Time to Response (TTR) During the First-line Treatment Phase	8.8; 10.6	—
SECONDARY Overall Survival (OS) for the First-line Treatment	12.9; 13.8	0.663
SECONDARY Progression Free Survival (PFS) During the Second-line Treatment Phase	4.2	—
SECONDARY Overall Response Rate (ORR) During the Second-line Treatment Phase	13.33	—
SECONDARY Rate of Disease Control (RDC) During the Second-line Treatment Phase	53.33	—
SECONDARY Duration of Response (DOR) During the Second-line Treatment Phase	NA	—
SECONDARY Time to Response (TTR) During the Second-line Treatment Phase	10.6	—
SECONDARY Overall Survival (OS) for the Second-line Treatment	8.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00454779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.