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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Carcinoma, Squamous

Thank you

Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 Weeks, 1 Year

Safety Issue:

No

Principal Investigator

Chao Huang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Food and Drug Administration

Study ID:

10635

NCT ID:

NCT00591149

Start Date:

June 2007

Completion Date:

April 2012

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous
  • cancer
  • head and neck cancer
  • squamous cell cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353