Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Phase 2TerminatedNCT00591149

University of Kansas Medical Center16 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Carcinoma, Squamous

Interventions

OxaliplatinDRUG

130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles

DocetaxelDRUG

60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles

CetuximabDRUG

400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Efficacy Measured by Response Rate in Participants

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.

Time frame: 12 Weeks, 1 Year

Data from ClinicalTrials.gov

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