CancerPhase 2RAD0503NCT00369512
A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma
A Phase 2 study testing Erlotinib in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven primary or recurrent squamous cell carcinoma arising from the lip or skin of the face, ear, scalp or neck.
- Participants must meet one of the four criteria:
- 1. T4 cutaneous SCC as determined by physical exam, imaging studies, prior resections or biopsy. T4 disease is defined as tumor that invades deep extradermal structures such as cartilage, skeletal muscle (e.g., muscles of facial expression), parotid gland or bone.Patients with a T2 or greater squamous cell carcinoma of the lower lip who will require post operative radiation will be allowed.
- 2. Histologically proven regional lymph node involvement (N1 disease). Fine needle aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.
- 3. Histologically proven parotid gland metastasis. Fine needle aspiration or biopsy can be used to demonstrate the presence of regional spread. Includes delayed regional metastasis; primary scalp or other skin lesion treated within 36 months that would drain into the involved parotid.
- 4. Patients who following surgical resection of the primary are found to have histologically positive lymph nodes (N1). Includes delayed regional metastasis; primary lip or cutaneous lesion treated within 36 months that would drain into the involved nodal basin.
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- Age > 19 years
- Tumors must be considered surgically resectable.(Patients may be enrolled after surgery is completed as long as Erlotinib therapy and concurrent radiation is started within 8 weeks of surgical resection.)
- Required laboratory data obtained prior to beginning treatment: WBC > 1,500/ml; Platelets > 90,000; serum creatinine ≤ 2.0 mg/dl
- The patient may have had a prior non-cutaneous malignancy, but must be two years from treatment.
- Performance status of ≤ 2 (ECOG scale) and life expectancy ≥ 12 months.
- The patients must agree to use effective contraception if there is the potential for procreativity. Contraception must be conducted for at least 3 months following the study.
- Patients must sign informed consent
Who cannot join
- The patient has received prior radiation therapy to the head and neck.
- The patient is pregnant or lactating
- Patients with a prior history of head and neck mucosal cancers.
- Psychological condition that renders the patient unable to understand the informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35233
About this study
Official title: A Phase II Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas
This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical resection. Following planned surgical resection, the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection.
Read the detailed description
This is a single-institution, open-label, non-randomized phase II trial of erlotinib administered concomitantly with radiation therapy following surgical resection of gross disease. A total of 45 patients with previously unirradiated, high-risk cutaneous SCC requiring post-operative radiotherapy will be enrolled to assess the primary endpoints of time to recurrence and disease free survival. Pretreatment biopsies will be required to confirm the histological diagnosis of SCC. Four to six weeks after surgical resection, patients will begin erlotinib (150 mg po qd) beginning the first day of radiotherapy. Patients will receive 5040 cGy beginning on day 1 of therapy in standard fractionations. Patients will be followed to evaluate for toxicity based on NCI common toxicity criteria (v3.0). Patients will be followed on protocol for a minimum of 2 years with regularly scheduled CT scans, clinical evaluations, and laboratory work. Patients with residual or recurrent cancer will be taken off protocol for salvage therapy.
As a secondary objective, molecular response of tumors to erlotinib monotherapy will be determined. When possible, participants will be enrolled and treated for 14 days with erlotinib prior to surgical resection. The pretreatment biopsy specimen (control) will then be compared to tissue acquired during the surgical resection after 14 days of erlotinib (experimental group).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva
Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd). Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.
Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events
Measured: 2 years
Median Time to Cancer Recurrence
Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.
Measured: 2 years
Number of Patients With Recurrence at 2 Years
Rate of recurrence at 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2012
- Study completionSep 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Responsible party
- Principal investigator, Eben Rosenthal, University of Alabama at Birmingham
- Investigators
- Eben Rosenthal, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369512
- Sponsor's protocol ID
- F060106002
- Acronym
- RAD0503
- Status last verified
- May 2017
- First submitted
- 24 Aug 2006
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heath CH, Deep NL, Nabell L, Carroll WR, Desmond R, Clemons L, Spencer S, Magnuson JS, Rosenthal EL. Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1275-81. doi: 10.1016/j.ijrobp.2012.09.030. Epub 2012 Nov 22.
PubMed 23182701
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT00369512
- Acronym / sponsor ID
- RAD0503 / F060106002
- Conditions
- Cancer
- Keywords
- Phase II, Erlotinib, Radiotherapy, Squamous Cell Carcinomas, Cutaneous, Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Study start
- Aug 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Posted 8 Aug 2013
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 phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical resection. Following planned surgical resection, the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection.
Detailed description
This is a single-institution, open-label, non-randomized phase II trial of erlotinib administered concomitantly with radiation therapy following surgical resection of gross disease. A total of 45 patients with previously unirradiated, high-risk cutaneous SCC requiring post-operative radiotherapy will be enrolled to assess the primary endpoints of time to recurrence and disease free survival. Pretreatment biopsies will be required to confirm the histological diagnosis of SCC. Four to six weeks after surgical resection, patients will begin erlotinib (150 mg po qd) beginning the first day of radiotherapy. Patients will receive 5040 cGy beginning on day 1 of therapy in standard fractionations. Patients will be followed to evaluate for toxicity based on NCI common toxicity criteria (v3.0). Patients will be followed on protocol for a minimum of 2 years with regularly scheduled CT scans, clinical evaluations, and laboratory work. Patients with residual or recurrent cancer will be taken off protocol for salvage therapy.
As a secondary objective, molecular response of tumors to erlotinib monotherapy will be determined. When possible, participants will be enrolled and treated for 14 days with erlotinib prior to surgical resection. The pretreatment biopsy specimen (control) will then be compared to tissue acquired during the surgical resection after 14 days of erlotinib (experimental group).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: ErlotinibErlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven primary or recurrent squamous cell carcinoma arising from the lip or skin of the face, ear, scalp or neck.
- Participants must meet one of the four criteria:
- 1. T4 cutaneous SCC as determined by physical exam, imaging studies, prior resections or biopsy. T4 disease is defined as tumor that invades deep extradermal structures such as cartilage, skeletal muscle (e.g., muscles of facial expression), parotid gland or bone.Patients with a T2 or greater squamous cell carcinoma of the lower lip who will require post operative radiation will be allowed.
- 2. Histologically proven regional lymph node involvement (N1 disease). Fine needle aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.
- 3. Histologically proven parotid gland metastasis. Fine needle aspiration or biopsy can be used to demonstrate the presence of regional spread. Includes delayed regional metastasis; primary scalp or other skin lesion treated within 36 months that would drain into the involved parotid.
Key exclusion criteria (4 listed)
- The patient has received prior radiation therapy to the head and neck.
- The patient is pregnant or lactating
- Patients with a prior history of head and neck mucosal cancers.
- Psychological condition that renders the patient unable to understand the informed consent.
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 |
|---|---|---|
| ErlotinibAlso: TarcevaErlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd). | Drug | Erlotinib |
Primary outcome
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.
Time frame: 2 years
Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events
Median Time to Cancer Recurrence
Time frame: 2 years
Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.
Number of Patients With Recurrence at 2 Years
Time frame: 2 years
Rate of recurrence at 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23182701Heath CH, Deep NL, Nabell L, Carroll WR, Desmond R, Clemons L, Spencer S, Magnuson JS, Rosenthal EL. Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1275-81. doi: 10.1016/j.ijrobp.2012.09.030. Epub 2012 Nov 22.
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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.
Eben Rosenthal, M.D. principal investigator
University of Alabama at Birmingham
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 Erlotinib in people with Cancer, run by University of Alabama at Birmingham 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 13 inclusion and 4 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 30 May 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 8 Aug 2013). 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?
Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00369512, which also lists 1 linked publication.
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 30 May 2017.