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

Amgen

Status and phase: Completed; Phase 2

Conditions: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: Docetaxel; Drug: Cisplatin; Drug: Panitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454779

20050236

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

Arm 1

Experimental group

Description:

Panitumumab + Docetaxel + Cisplatin

Treatment:

Drug: Cisplatin

Drug: Docetaxel

Drug: Docetaxel

Drug: Cisplatin

Drug: Panitumumab

Arm 2

Other group

Description:

control

Treatment:

Drug: Cisplatin

Drug: Docetaxel

Drug: Docetaxel

Drug: Cisplatin