Head and Neck CancerPhase 2NCT00713219
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer
A Phase 2 study testing IMRT, cetuximab, docetaxel in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
This is a study for patients who have head and neck cancer that has recurred in the body area where they previously received radiation, and for whom surgery is not planned. A widely accepted treatment option in this situation is chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- IMRT, cetuximab, docetaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2008to Apr 2013
- 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
- Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or second primary head and neck squamous cell carcinoma (HNSCC) in patients with past history of definitive radiation therapy for head and neck cancer. Patients in whom the initial diagnosis was neck metastasis with suspected occult primary in the head and neck will be eligible.
- Patients with histologic variants such as spindle cell carcinoma, poorly-differentiated keratin positive carcinoma, and lymphoepithelioma will be eligible.
- Patients may be eligible if they have unresected recurrent disease in the prior radiation field. Patients also may be eligible if they have undergone surgical resection of recurrent disease in the prior radiation field with any of the following poor risk pathologic features:
- Malignant involvement of 2 or more regional lymph nodes
- Extracapsular extension of nodal disease
- Microscopically involved mucosal margins of resection (at 5 mM or less)
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- Perineural involvement
- Resected soft tissue disease
- Oral cavity or oropharyngeal primaries with nodal disease at levels IV or V
- Patients must have had prior radiation for head and neck cancer with ≥ 50 % of the recurrent tumor within areas that have been radiated to at least 45 Gy, but not exceeding 72 Gy.
- Greater than 6 month interval from prior external beam radiation treatment. (Patients who have received intra-operative radiation therapy [IORT] within 6 months of registration may be eligible, if there has been no subsequent disease recurrence in the IORT field and criteria for eligibility are otherwise met).
- KPS > or = to 70%
- Age > or = to 18years
- Adequate bone marrow function: ANC > or = to 1,500/μl, platelets > or = to 100,000/μl, Hgb > or = to 8 g/dL.
- Adequate hepatic function.
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least three months thereafter.
- Patient must sign an informed consent document.
Who cannot join
- Anticipated lifetime spinal cord dose exceeding 54 Gy, brain stem exceeding 65 Gy, optic chiasm exceeding 55 Gy, and optic nerves exceeding 60 Gy.
- Three or more palliative cytotoxic chemotherapy regimens in the recurrent or metastatic disease setting.
- Pregnancy or lactation.
- Distant metastatic disease.
- Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with nonmelanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.
- Serious concomitant medical disorders (for example, active infection, uncontrolled seizure disorder, unstable angina) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
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- History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate-80.
- History of severe infusion reaction to a monoclonal antibody.
- Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07939
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oncology/Hematology West
Omaha, Nebraska, 68114
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
About this study
Official title: Phase II Study of Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity -Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer
This is a study for patients who have head and neck cancer that has recurred in the body area where they previously received radiation, and for whom surgery is not planned. A widely accepted treatment option in this situation is chemotherapy alone. Another approach that has been used in clinical trials is to treat patients with a repeat course of radiation. In these studies, some patients received chemotherapy at the same time as the radiation.
In this clinical study, we wish to treat with radiation plus two drugs during the course of reirradiation, Taxotere® (docetaxel) and Erbitux® (cetuximab). Docetaxel and cetuximab both are chemotherapy drugs which are administered by vein. Both drugs help radiation kill cancer cells.
Read more
The radiation will be administered using a strategy called intensity-modulated radiation therapy (IMRT), which focuses the radiation beam on the tumor.
Docetaxel and cetuximab are both approved for the treatment of patients with head and neck cancer.
However, the combination of radiation + docetaxel + cetuximab for patients with recurrent head and neck cancer is considered to be a topic for clinical research. The purpose of this study is to determine the good and bad effects of treatment with radiation + docetaxel + cetuximab.
- Conditions
- Head and Neck Cancer
- Being tested
- IMRT, cetuximab, docetaxel
- Keywords
- IMRT, cetuximab, docetaxel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT, cetuximab, docetaxelRadiation
IMRT will be administered in once daily fractions (2 Gy/day, Monday through Friday) over approximately 7 weeks to a goal of approximately 70 Gy. The chemotherapy regimen will begin with a loading dose of intravenous cetuximab (400 mg/m2) one week prior to the initiation of radiation therapy, followed by weekly administration of intravenous docetaxel (15 mg/m2) and intravenous cetuximab (250 mg/m2) for approximately 7 weeks concurrently with radiation. Patients will be evaluated weekly prior to their chemotherapy. All patients will be evaluated on an intention-to-treat basis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CHEMORADIATION Receives: Radiation: IMRT, cetuximab, docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Progression-Free Survival (PFS).
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2013
- Study completionApr 2013
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 Memorial Sloan Kettering Cancer 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology/Hematology West
- Responsible party
- Sponsor
- Investigators
- Matthew Fury, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713219
- Sponsor's protocol ID
- 08-050
- Status last verified
- Apr 2015
- First submitted
- 9 Jul 2008
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity -Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00713219
- Acronym / sponsor ID
- 08-050
- Conditions
- Head and Neck Cancer
- Keywords
- IMRT, cetuximab, docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Oncology/Hematology West
- Study start
- Jul 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Posted 23 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study for patients who have head and neck cancer that has recurred in the body area where they previously received radiation, and for whom surgery is not planned. A widely accepted treatment option in this situation is chemotherapy alone. Another approach that has been used in clinical trials is to treat patients with a repeat course of radiation. In these studies, some patients received chemotherapy at the same time as the radiation.
In this clinical study, we wish to treat with radiation plus two drugs during the course of reirradiation, Taxotere® (docetaxel) and Erbitux® (cetuximab). Docetaxel and cetuximab both are chemotherapy drugs which are administered by vein. Both drugs help radiation kill cancer cells.
The radiation will be administered using a strategy called intensity-modulated radiation therapy (IMRT), which focuses the radiation beam on the tumor.
Docetaxel and cetuximab are both approved for the treatment of patients with head and neck cancer.
However, the combination of radiation + docetaxel + cetuximab for patients with recurrent head and neck cancer is considered to be a topic for clinical research. The purpose of this study is to determine the good and bad effects of treatment with radiation + docetaxel + cetuximab.
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 | Radiation: IMRT, cetuximab, docetaxelCHEMORADIATION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or second primary head and neck squamous cell carcinoma (HNSCC) in patients with past history of definitive radiation therapy for head and neck cancer. Patients in whom the initial diagnosis was neck metastasis with suspected occult primary in the head and neck will be eligible.
- Patients with histologic variants such as spindle cell carcinoma, poorly-differentiated keratin positive carcinoma, and lymphoepithelioma will be eligible.
- Patients may be eligible if they have unresected recurrent disease in the prior radiation field. Patients also may be eligible if they have undergone surgical resection of recurrent disease in the prior radiation field with any of the following poor risk pathologic features:
- Patients must have had prior radiation for head and neck cancer with ≥ 50 % of the recurrent tumor within areas that have been radiated to at least 45 Gy, but not exceeding 72 Gy.
- Greater than 6 month interval from prior external beam radiation treatment. (Patients who have received intra-operative radiation therapy [IORT] within 6 months of registration may be eligible, if there has been no subsequent disease recurrence in the IORT field and criteria for eligibility are otherwise met).
Key exclusion criteria (9 listed)
- Anticipated lifetime spinal cord dose exceeding 54 Gy, brain stem exceeding 65 Gy, optic chiasm exceeding 55 Gy, and optic nerves exceeding 60 Gy.
- Three or more palliative cytotoxic chemotherapy regimens in the recurrent or metastatic disease setting.
- Pregnancy or lactation.
- Distant metastatic disease.
- Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with nonmelanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.
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 |
|---|---|---|
| IMRT, cetuximab, docetaxelIMRT will be administered in once daily fractions (2 Gy/day, Monday through Friday) over approximately 7 weeks to a goal of approximately 70 Gy. The chemotherapy regimen will begin with a loading dose of intravenous cetuximab (400 mg/m2) one week prior to the initiation of radiation therapy, followed by weekly administration of intravenous docetaxel (15 mg/m2) and intravenous cetuximab (250 mg/m2) for approximately 7 weeks concurrently with radiation. Patients will be evaluated weekly prior to their chemotherapy. All patients will be evaluated on an intention-to-treat basis. | Radiation | 1 |
Primary outcome
Overall Progression-Free Survival (PFS).
Time frame: conclusion of the study
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Matthew Fury, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMRT, cetuximab, docetaxel in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites 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 18 inclusion and 9 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: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 23 Apr 2015). 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?
Overall Progression-Free Survival (PFS). (time frame: conclusion of the study). 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 23 Apr 2015.