Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Head and Neck Cancer Carcinoma, Squamous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

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

Docetaxel

Intervention Type DRUG

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

Cetuximab

Intervention Type DRUG

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

Interventions

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Oxaliplatin

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

Intervention Type DRUG

Docetaxel

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

Intervention Type DRUG

Cetuximab

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

Intervention Type DRUG

Other Intervention Names

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Eloxatin Taxotere Erbitux

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No