Back to resultsOxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Carcinoma, Squamous
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Docetaxel
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring cancer, head and neck cancer, squamous cell cancer
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
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.
Outcomes
Primary Outcome Measures
Efficacy Measured by Response Rate in Participants
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00591149
First Posted
December 27, 2007
Last Updated
May 16, 2017
Sponsor
University of Kansas Medical Center
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00591149
Brief Title
Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to termination of funding
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Carcinoma, Squamous
Keywords
cancer, head and neck cancer, squamous cell cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Primary Outcome Measure Information:
Title
Efficacy Measured by Response Rate in Participants
Description
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.
Time Frame
12 Weeks, 1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao Huang, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
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