Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

University of Kansas

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Squamous; Head and Neck Cancer

Treatments: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Cetuximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00591149

10635

Details and patient eligibility

About

A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Full description

This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed recurrent SCCHN
• 18 years or older
• Tumor site accessible by biopsy
• Measurable disease
• Receiving no other therapy
• ECOG performance status 0-1
• Adequate bone marrow, renal function and hepatic function

Exclusion criteria

• Active infection or fever within 3 days of treatment
• Active CNS metastases
• Prior malignancy within 5 years
• Hypersensitivity to study drugs
• Chemotherapy within 30 days of treatment
• Concurrent investigational therapy within 30 days
• Radiotherapy of more than 25% of bone marrow
• Peripheral neuropathy of grade 2 or greater
• Pregnant or lactating patients
• History of allogeneic transplant
• Active or previously treated HIV or Hepatitis B or C
• Patients with a tracheostomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

1

Experimental group

Description:

Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.

Treatment:

Drug: Cetuximab

Drug: Oxaliplatin

Drug: Docetaxel