Head and Neck CancerPhase 2NCT00591149
Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
A Phase 2 study testing Oxaliplatin, Docetaxel and Cetuximab in people with Head and Neck Cancer and Carcinoma, Squamous, run by University of Kansas Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Carcinoma, Squamous
- What is being tested?
- Oxaliplatin, Docetaxel and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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)
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
Read the 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.
- Conditions
- Head and Neck Cancer, Carcinoma, Squamous
- Being tested
- Oxaliplatin, Docetaxel, Cetuximab
- Keywords
- cancer, head and neck cancer, squamous cell cancer
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Eloxatin
130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
DocetaxelDrug
Also called Taxotere
60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
CetuximabDrug
Also called Erbitux
400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Drug: Oxaliplatin; Drug: Docetaxel; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Study was stopped due to termination of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Chao Huang, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591149
- Sponsor's protocol ID
- 10635
- Status last verified
- May 2017
- First submitted
- 27 Dec 2007
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00591149
- Acronym / sponsor ID
- 10635
- Conditions
- Head and Neck Cancer, Carcinoma, Squamous
- Keywords
- cancer, head and neck cancer, squamous cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to termination of funding
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jun 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxaliplatin, Drug: Docetaxel, Drug: CetuximabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed recurrent SCCHN
- 18 years or older
- Tumor site accessible by biopsy
- Measurable disease
- Receiving no other therapy
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAlso: Eloxatin130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles | Drug | 1 |
| DocetaxelAlso: Taxotere60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles | Drug | 1 |
| CetuximabAlso: Erbitux400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks | Drug | 1 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Huang, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Docetaxel and Cetuximab in people with Head and Neck Cancer and Carcinoma, Squamous, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Measured by Response Rate in Participants (time frame: 12 Weeks, 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.