Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Phase 2

Terminated

Conditions: Head and Neck Cancer
Carcinoma, Squamous

Interventions: Drug: Oxaliplatin
Drug: Docetaxel
Drug: Cetuximab

Registration Number: NCT00591149

Lead Sponsor: University of Kansas Medical Center

Brief 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

Detailed 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 & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 16

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	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.
1	Oxaliplatin	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.
1	Cetuximab	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.

Primary Outcome Measures

Name	Time	Method
Efficacy Measured by Response Rate in Participants	12 Weeks, 1 Year	Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: * Complete Response (CR), Disappearance of all target lesions; * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.