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:

Minneapolis Veterans Affairs Medical Center

ClinicalTrials.gov Identifier:

NCT00557206

First received: November 9, 2007

Last updated: August 10, 2011

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2007

Last Updated Date

August 10, 2011

Start Date ^ICMJE

April 2005

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response rate as determined by RECIST criteria every 6 weeks. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Response rate as determined by RECIST criteria every 6 weeks. [ Time Frame: Patients will be on the trial until disease progression and/or unacceptable toxicity. ]

Change History

Complete list of historical versions of study NCT00557206 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Toxicity and Quality of Life assessments every 3 weeks. [ Time Frame: Patients will be monitored while on the trial, until disease progression and/or unacceptable toxicity. ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Neoplasms
Head and Neck Neoplasms

Intervention ^ICMJE

Drug: Oxaliplatin and Docetaxel

Chemotherapy

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

Study Arm (s)

Experimental: 1

This is a single arm trial.

Intervention: Drug: Oxaliplatin and Docetaxel

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00557206

Other Study ID Numbers ^ICMJE

OX-04-033, VA-CORNET

Has Data Monitoring Committee

Responsible Party

Balkrishna Jahagirdar, MD; Principal Investigator, VA CORNET (VA Clinical Oncology Research Network)

Study Sponsor ^ICMJE

Minneapolis Veterans Affairs Medical Center

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

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

Information Provided By

Minneapolis Veterans Affairs Medical Center

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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