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Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

This study has been terminated.
(Funding was terminated)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Balkrishna Jahagirdar, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00557206
First received: November 9, 2007
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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

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

Chemotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557206

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

Publications:
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, VA-CORNET
Study First Received: November 9, 2007
Last Updated: November 4, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Carcinoma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Docetaxel
Oxaliplatin
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014