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Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00591149
Recruitment Status : Terminated (Study was stopped due to termination of funding)
First Posted : January 11, 2008
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Carcinoma, Squamous Drug: Oxaliplatin Drug: Docetaxel Drug: Cetuximab Phase 2

Detailed Description:
This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Study Start Date : June 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1

Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.

Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.

Drug: Oxaliplatin
130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Other Name: Eloxatin

Drug: Docetaxel
60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Other Name: Taxotere

Drug: Cetuximab
400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Other Name: Erbitux




Primary Outcome Measures :
  1. Efficacy Measured by Response Rate in Participants [ Time Frame: 12 Weeks, 1 Year ]

    Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI:

    • Complete Response (CR), Disappearance of all target lesions;
    • Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;
    • Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started;
    • Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.



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

Inclusion Criteria:

  • Histologically or cytologically confirmed recurrent SCCHN
  • 18 years or older
  • Tumor site accessible by biopsy
  • Measurable disease
  • Receiving no other therapy
  • ECOG performance status 0-1
  • Adequate bone marrow, renal function and hepatic function

Exclusion Criteria:

  • Active infection or fever within 3 days of treatment
  • Active CNS metastases
  • Prior malignancy within 5 years
  • Hypersensitivity to study drugs
  • Chemotherapy within 30 days of treatment
  • Concurrent investigational therapy within 30 days
  • Radiotherapy of more than 25% of bone marrow
  • Peripheral neuropathy of grade 2 or greater
  • Pregnant or lactating patients
  • History of allogeneic transplant
  • Active or previously treated HIV or Hepatitis B or C
  • Patients with a tracheostomy

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): NCT00591149


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Sanofi
Investigators
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Principal Investigator: Chao Huang, MD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00591149     History of Changes
Other Study ID Numbers: 10635
First Posted: January 11, 2008    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Keywords provided by University of Kansas Medical Center:
cancer
head and neck cancer
squamous cell cancer
Additional relevant MeSH terms:
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Carcinoma
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Docetaxel
Oxaliplatin
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological