Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

November 4, 2013 updated by: Balkrishna Jahagirdar, Minneapolis Veterans Affairs Medical Center

Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
This is a single arm trial.
Drug: Oxaliplatin and Docetaxel

Chemotherapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate as determined by RECIST criteria every 6 weeks.
Time Frame: 2 Years
2 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity and Quality of Life assessments every 3 weeks.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Veterans Affairs Medical Center

Collaborators

Sanofi

Investigators

  • Principal Investigator: Balkrishna Jahagirdar, MD, Minneapolis Veterans Affairs Medical Center
  • Principal Investigator: Vicki A Morrison, MD, Minneapolis Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OX-04-033
  • VA-CORNET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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