Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00591149
• Other study ID #: 10635
• Status: Terminated
• Phase: Phase 2
• First received: December 27, 2007
• Last updated: April 2, 2013
• Start date: June 2007
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Oxaliplatin
130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
• Docetaxel
60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
• Cetuximab
400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as determined by RECIST criteria (CR and PR) will be used to determine efficacy in terms of reduction of tumor size and control of disease		12 Weeks, 1 Year	No