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Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

This study has been terminated.
(Funding was terminated)
Information provided by (Responsible Party):
Balkrishna Jahagirdar, Minneapolis Veterans Affairs Medical Center Identifier:
First received: November 9, 2007
Last updated: November 4, 2013
Last verified: November 2013
Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.

Condition Intervention Phase
Head and Neck Neoplasms
Drug: Oxaliplatin and Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Resource links provided by NLM:

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Response rate as determined by RECIST criteria every 6 weeks. [ Time Frame: 2 Years ]

Secondary Outcome Measures:
  • Toxicity and Quality of Life assessments every 3 weeks. [ Time Frame: 2 years ]

Enrollment: 35
Study Start Date: April 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This is a single arm trial.
Drug: Oxaliplatin and Docetaxel


Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.

Detailed Description:

Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2 given on day 1 by intravenous injection

Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic or locoregionally recurrent SCCHN deemed incurable by local therapy
  • Measureable disease
  • No prior use of palliative chemo after the SCCHN is deemed incurable by local therapy
  • No prior treatment with oxaliplatin or docetaxel
  • 18 years of age or older
  • ECOG Performance status 0-1
  • ANC 1,500/mcl or greater
  • Adequate renal function
  • Adequate liver function
  • Recovered from acute and late effects of any prior treatment with a minimum of 4 weeks from the last session to enrollment in the study
  • Patient or their legal representative must be able to read, understand, and provide informed consent
  • Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication

Exclusion Criteria:

  • Patients with an active documented infection or with a fever (38.5 degrees celsius or higher) within 3 days of the first scheduled dose of study treatment
  • Patients with active CNS metastases
  • Hypercalcemia related to SCCHN
  • History of prior malignancy with the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia or localized prostate cancer
  • Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel or to other drugs formulated with polysorbate 90
  • Patients receiving concurrent investigational therapy or investigational therapy less than 30 days from first scheduled dose of study therapy
  • Peripheral neuropathy grade 2 or higher
  • Any medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
  • History of allogeneic transplant
  • Known HIV or Hepatitis B or C (active, previously treated or both)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00557206

United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Principal Investigator: Balkrishna Jahagirdar, MD Minneapolis Veterans Affairs Medical Center
Principal Investigator: Vicki A Morrison, MD Minneapolis Veterans Affairs Medical Center
  More Information

Responsible Party: Balkrishna Jahagirdar, Principal Investigator, Minneapolis Veterans Affairs Medical Center Identifier: NCT00557206     History of Changes
Other Study ID Numbers: OX-04-033
Study First Received: November 9, 2007
Last Updated: November 4, 2013

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Recurrent Disease
Metastatic Disease
Squamous Cell Carcinoma
Phase II

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017