Head and Neck CancerPhase 2NCT00904345
Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
A Phase 2 study testing Cetuximab and 50-60 Gy and 70 Gy in people with Head and Neck Cancer, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial summary
This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cetuximab and 50-60 Gy and 70 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Dec 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.
- Patients will be limited to:
- ≥ 70 years of age, OR
- with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR
- KPS ≤ 80, OR
- Creatinine clearance < 30 cc/min
Show all 13Show fewer
- Laboratory criteria:
- WBC > 3500/ul
- Granulocyte > 1500/ul
- Platelet count > 100,000/ul
- Total Bilirubin < 1.5 X ULN
- AST and ALT < 2.5 X ULN
- Patients must give documented informed consent to participate in this study.
Who cannot join
- Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
- Prior head and neck radiation or chemotherapy.
- Documented evidence of distant metastases.
- Patients with nasopharyngeal carcinoma.
- Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.
- Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
- Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).
- Patients residing in prison.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Michigan Veterans Administration Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities
This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.
Read the detailed description
Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.
Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.
Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.
Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.
Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.
- Conditions
- Head and Neck Cancer
- Being tested
- Cetuximab, 50-60 Gy and 70 Gy
- Keywords
- SCC Head and Neck Cancer
- 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.
CetuximabDrug
Patients will receive a single dose of cetuximab 400 mg/m (Day 0). On day 7 (+/- 1 day), a repeat biopsy will be performed. Radiation concurrent with weekly cetuximab 250 mg/m.
50-60 Gy and 70 GyRadiation
Within approximately 4 days (after single dose of Cetuximab), definitive radiation will begin (70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes) concurrent with weekly cetuximab 250 mg/m.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Cetuximab; Radiation: 50-60 Gy and 70 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Measured: At baseline (pre-loading dose) and day 7 post-loading dose
Mean Change in Tumor Phosphorylated EGFR (pEGFR)
The ratio (fold change) of tumor pEGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Measured: At baseline (pre-loading dose) and day 7 post-loading dose
Progression Free Survival Rate
Percentage of participants who survived without recurrent disease, from the time of enrollment to 1 and 2 years.
Measured: At 1 and 2 years
Overall Survival Rate
Percentage of participants alive at 1 and 2 years after enrollment.
Measured: At 1 and 2 Years
Number of Participants With Treatment Related Toxicities
Toxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the total number of incidents outnumbers the number of participants. Toxicities are graded according to the CTCAE v4.
Measured: 3 years
Secondary outcomes (2)
Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa
Normal mucosa EGFR was assessed for comparison with EGFR in tumor sample. The fold change in tumor EGFR level at post-loading dose/pre-loading dose of cetuximab, relative to fold change in normal mucosa EGFR level post-loading dose/pre-loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal EGFR.
Measured: At baseline (pre-loading dose) and day 7 post-loading dose
Change in Tumor pEGFR Level Relative to pEGFR in Normal Mucosa
Normal mucosa pEGFR was assessed for comparison with pEGFR in tumor sample. The fold change in tumor pEGFR level post-loading dose/pre loading dose of cetuximab, relative to fold change in normal mucosa pEGFR level post-loading dose/pre-loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal pEGFR.
Measured: At baseline (pre-loading dose) and day 7 post-loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: Stopped early for funding and efficacy reasons.
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 Michigan Rogel 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shruti Jolly, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904345
- Sponsor's protocol ID
- UMCC 2009.009
- Other IDs
- HUM 27253
- Status last verified
- Feb 2021
- First submitted
- 17 May 2009
- Last updated
- 24 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities
- ClinicalTrials.gov ID
- NCT00904345
- Acronym / sponsor ID
- UMCC 2009.009
- Conditions
- Head and Neck Cancer
- Keywords
- SCC Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped early for funding and efficacy reasons.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Posted 20 Jan 2021
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 single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.
Detailed description
Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.
Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.
Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.
Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.
Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Cetuximab, Radiation: 50-60 Gy and 70 Gy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.
- Patients will be limited to:
- Laboratory criteria:
- Patients must give documented informed consent to participate in this study.
Key exclusion criteria (8 listed)
- Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
- Prior head and neck radiation or chemotherapy.
- Documented evidence of distant metastases.
- Patients with nasopharyngeal carcinoma.
- Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this 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 |
|---|---|---|
| CetuximabPatients will receive a single dose of cetuximab 400 mg/m (Day 0). On day 7 (+/- 1 day), a repeat biopsy will be performed. Radiation concurrent with weekly cetuximab 250 mg/m. | Drug | Treatment |
| 50-60 Gy and 70 GyWithin approximately 4 days (after single dose of Cetuximab), definitive radiation will begin (70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes) concurrent with weekly cetuximab 250 mg/m. | Radiation | Treatment |
Primary outcome
Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
Time frame: At baseline (pre-loading dose) and day 7 post-loading dose
The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Mean Change in Tumor Phosphorylated EGFR (pEGFR)
Time frame: At baseline (pre-loading dose) and day 7 post-loading dose
The ratio (fold change) of tumor pEGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Progression Free Survival Rate
Time frame: At 1 and 2 years
Percentage of participants who survived without recurrent disease, from the time of enrollment to 1 and 2 years.
Overall Survival Rate
Time frame: At 1 and 2 Years
Percentage of participants alive at 1 and 2 years after enrollment.
Number of Participants With Treatment Related Toxicities
Time frame: 3 years
Toxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the total number of incidents outnumbers the number of participants. Toxicities are graded according to the CTCAE v4.
2 secondary outcomes
Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa
Time frame: At baseline (pre-loading dose) and day 7 post-loading dose
Change in Tumor pEGFR Level Relative to pEGFR in Normal Mucosa
Time frame: At baseline (pre-loading dose) and day 7 post-loading dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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.
Shruti Jolly, MD principal investigator
University of Michigan Rogel Cancer Center
2 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 Cetuximab and 50-60 Gy and 70 Gy in people with Head and Neck Cancer, run by University of Michigan Rogel Cancer Center at 2 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 13 inclusion and 8 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 20 Jan 2021). 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?
Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR) (time frame: At baseline (pre-loading dose) and day 7 post-loading dose). The study lists 5 primary outcomes in all. 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 24 Feb 2021.