Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas; University of Kansas Medical Center
• Collaborator: Sanofi
• Treatments: Cetuximab; Docetaxel; Oxaliplatin

Criteria

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