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Trial record 20 of 1254 for:    veterans affairs medical center

Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00557206
Recruitment Status : Terminated (Funding was terminated)
First Posted : November 12, 2007
Last Update Posted : November 5, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.

Condition or disease Intervention/treatment Phase
Neoplasms Head and Neck Neoplasms Drug: Oxaliplatin and Docetaxel Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2005
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

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

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

Eligibility Criteria

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00557206     History of Changes
Other Study ID Numbers: OX-04-033
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Keywords provided by Balkrishna Jahagirdar, 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