Head and Neck CancerPhase 2NCT01427205
Phase II Study of Cetuximab With or Without OSI-906 in Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 2 study testing Cetuximab and OSI-906 in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab can improve response. The safety of these drugs will also be studied. Objectives: Primary Objective(s): To assess progression-free survival (PFS) among patients with head and neck squamous cell carcinoma (HNSCC) treated with a… 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?
- Cetuximab and OSI-906
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients must have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
- Patients must be willing to have a biopsy of tumor tissue for biomarker analysis.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). Measurable lymph nodes are required to be >/= 15 mm in size (short axis diameter). Measurable disease in previously radiated areas is acceptable as long as there has been documented progression.
- Patients must have disease progression: 1) After platinum-based chemotherapy for recurrent/metastatic disease OR 2) Within 6 months of receiving definitive platinum-based combined modality therapy.
- Previous treatment with cetuximab is allowed, as long as there has been a period >/= 6 months between the last cetuximab treatment and randomization
- All prior cytotoxic therapy must have been completed at least three weeks prior to treatment on study.
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- Age >/= 18 years
- ECOG performance status </= 2 or Karnofsky >/= 60%
- Patients must have normal liver function as defined below: total bilirubin </= institutional upper limit of normal and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) </= 2.5 * institutional upper limit of normal.
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
- Patients must provide verbal and written informed consent to participate in this study
- Prior radiation treatment is acceptable as long as it has been completed one week prior to treatment on protocol.
Who cannot join
- Patients may not be receiving any other investigational agents with anti-cancer activity.
- Patients with known, untreated brain metastases. Patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed >/= 28 days prior to study entry and if clinical neurologic function is stable.
- History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906 or other agents used in the study.
- QTc interval > 450 msec at baseline.
- Concomitant drugs with a generally accepted risk of causing Torsades de Pointes
- Congestive heart failure, New York Heart Association (NYHA) Class III or IV
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- History of arrhythmia which is symptomatic and requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled on medication are not excluded.
- Fasting blood sugar > 150 mg/dl at baseline
- Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
- Pregnant or breast-feeding females.
About this study
Official title: Phase II Study of Cetuximab With or Without OSI-906, a Dual Insulin-like Growth Factor-1 Receptor and an Insulin Receptor Inhibitor, in Platinum-Refractory, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab can improve response. The safety of these drugs will also be studied.
Objectives:
Read more
Primary Objective(s): To assess progression-free survival (PFS) among patients with head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and compare it with PFS among patients treated with cetuximab plus placebo.
Secondary Objective(s):
- To assess the safety and toxicity of these treatment regimens.
- To assess the efficacy of these two treatment regimens in terms of overall survival, response rate, and disease control rate
- To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of response rate and disease control rate in patients who cross-over from Arm B to receive single-agent OSI-906
- To explore blood-based and tissue biomarkers
Read the detailed description
Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking proteins on the cancer cell, called the epidermal growth factor receptor (EGFR).
OSI-906 is designed to prevent or slow the growth of cancer cells.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
- If you are in Group 1, you will receive cetuximab and OSI-906.
- If you are in Group 2, you will receive cetuximab and a placebo.
Neither you nor the study doctor will know if you are receiving OSI-906 or the placebo. However, if needed for your safety, the study doctor will be able to find out which group you are in.
If the disease gets worse, the study doctor will find out which group you were in and you will be offered the chance to take OSI-906 alone if you were not already receiving it.
Study Drug Administration:
Each cycle is 21 days.
On Days 1, 8, and 15 of each cycle, you will receive cetuximab by vein. The first dose of cetuximab will be given over about 120 minutes. If it is well tolerated, each additional infusion will be given over about 60 minutes.
You will take OSI-906 or placebo by mouth 2 times every day about 12 hours apart (in the morning and evening).
You should take OSI-906 or placebo with food and a glass (up to 6 ½ ounces) of water. If you forget to take a dose, you can take it any time up to 6 hours before the next dose. You must not take the missed dose with the next dose on that same day or with a dose the next day. If you vomit after taking the tablet(s), the dose should be replaced only if the tablet(s) can actually be seen and counted. You should store the study drug/placebo at room temperature below 77°F.
In order to help decrease the risk of infusion reaction, you will receive Benadryl (diphenhydramine) by vein before the first dose of cetuximab. If the doctor thinks it is needed, you will receive diphenhydramine before every dose of cetuximab.
On Day 1 of each cycle, you will need to return all unused OSI-906 or placebo and the empty bottles.
Study Visits:
At every visit, you will be asked if you have had any side effects and to list any drugs you may be taking.
On Day 1 of each cycle (+/- 7 days):
- You will have a physical exam, including measurement of your weight.
- Blood (about 3 teaspoons) will be drawn for routine tests. You should not eat or drink anything (fast) for 8 hours before this blood draw.
- If the doctor thinks it is needed and you are able to become pregnant, you will have a blood (less than 1 teaspoon) or urine pregnancy test.
On Days 1, 8, and 15 of each cycle, your vital signs will be measured before and after you receive cetuximab.
Every 6 weeks (+/- 14 days):
- You will have an ECG.
- You will have a CT scan and/or MRI scan to check the status of the disease.
Length of Study:
You may continue to receive treatment as long as you are benefitting. You will be taken off study early if you experience any intolerable side effects, the disease get worse, the doctor thinks it is your best interest, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment and follow-up visits.
End-of-Treatment Visit:
Within 30 days after the last dose of study drugs/placebo, you will have an end-of-treatment visit:
- You will have a physical exam, including measurement of your vital signs and weight
- You will be asked if you have had any side effects and to list any drugs you may be taking.
- Blood (about 3-4 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a CT scan or MRI scan to check the status of the disease.
Long Term Follow-Up:
About every 6 months from then on, you (or your family members or designees) will be asked about how you are doing and what treatments you may be receiving. This may be by phone, letter, email, or during clinic visits.
This is an investigational study. OSI-906 is not FDA approved or commercially available. At this time, OSI-906 is only being used in research. Cetuximab is FDA approved and commercially available for the treatment of colorectal and head/ neck cancer. The combination of OSI-906 and cetuximab is investigational.
Up to 66 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Head and Neck Cancer
- Being tested
- Cetuximab, OSI-906, Placebo
- Keywords
- Head and Neck Squamous Cell Carcinoma, HNSCC, recurrent, metastatic, oral cavity, Cetuximab, C225, Erbitux, IMC-C225, OSI-906, Placebo, sugar pill, oropharynx, larynx, hypopharynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called C225, Erbitux, IMC-C225
Loading dose 400 mg/m2 by vein once followed by 250 mg/m2 weekly (+/- 7 days).
OSI-906Drug
150 mg by mouth twice a day.
PlaceboOther
Also called sugar pill
Placebo taken by mouth twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cetuximab + OSI-906 | Experimental | Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + OSI-906 150 mg orally twice a day. 21-Day Cycle. Receives: Drug: Cetuximab; Drug: OSI-906 |
| Group B: Cetuximab + Placebo | Experimental | Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + Placebo orally twice a day. 21-Day Cycle. Receives: Drug: Cetuximab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is time to progressive disease or death of any cause from randomization date, assessed every 6 weeks with a total study period of approximately 24 months.
Measured: From treatment initiation to progressive disease or death, up to 24 months for study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- William N. William Jr., MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427205
- Sponsor's protocol ID
- 2010-0680
- Status last verified
- Apr 2013
- First submitted
- 30 Aug 2011
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cetuximab With or Without OSI-906, a Dual Insulin-like Growth Factor-1 Receptor and an Insulin Receptor Inhibitor, in Platinum-Refractory, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01427205
- Acronym / sponsor ID
- 2010-0680
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Squamous Cell Carcinoma, HNSCC, recurrent, metastatic, oral cavity, Cetuximab, C225, Erbitux
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab can improve response. The safety of these drugs will also be studied.
Objectives:
Primary Objective(s): To assess progression-free survival (PFS) among patients with head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and compare it with PFS among patients treated with cetuximab plus placebo.
Secondary Objective(s):
- To assess the safety and toxicity of these treatment regimens.
- To assess the efficacy of these two treatment regimens in terms of overall survival, response rate, and disease control rate
- To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of response rate and disease control rate in patients who cross-over from Arm B to receive single-agent OSI-906
- To explore blood-based and tissue biomarkers
Detailed description
Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking proteins on the cancer cell, called the epidermal growth factor receptor (EGFR).
OSI-906 is designed to prevent or slow the growth of cancer cells.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
- If you are in Group 1, you will receive cetuximab and OSI-906.
- If you are in Group 2, you will receive cetuximab and a placebo.
Neither you nor the study doctor will know if you are receiving OSI-906 or the placebo. However, if needed for your safety, the study doctor will be able to find out which group you are in.
If the disease gets worse, the study doctor will find out which group you were in and you will be offered the chance to take OSI-906 alone if you were not already receiving it.
Study Drug Administration:
Each cycle is 21 days.
On Days 1, 8, and 15 of each cycle, you will receive cetuximab by vein. The first dose of cetuximab will be given over about 120 minutes. If it is well tolerated, each additional infusion will be given over about 60 minutes.
You will take OSI-906 or placebo by mouth 2 times every day about 12 hours apart (in the morning and evening).
You should take OSI-906 or placebo with food and a glass (up to 6 ½ ounces) of water. If you forget to take a dose, you can take it any time up to 6 hours before the next dose. You must not take the missed dose with the next dose on that same day or with a dose the next day. If you vomit after taking the tablet(s), the dose should be replaced only if the tablet(s) can actually be seen and counted. You should store the study drug/placebo at room temperature below 77°F.
In order to help decrease the risk of infusion reaction, you will receive Benadryl (diphenhydramine) by vein before the first dose of cetuximab. If the doctor thinks it is needed, you will receive diphenhydramine before every dose of cetuximab.
On Day 1 of each cycle, you will need to return all unused OSI-906 or placebo and the empty bottles.
Study Visits:
At every visit, you will be asked if you have had any side effects and to list any drugs you may be taking.
On Day 1 of each cycle (+/- 7 days):
- You will have a physical exam, including measurement of your weight.
- Blood (about 3 teaspoons) will be drawn for routine tests. You should not eat or drink anything (fast) for 8 hours before this blood draw.
- If the doctor thinks it is needed and you are able to become pregnant, you will have a blood (less than 1 teaspoon) or urine pregnancy test.
On Days 1, 8, and 15 of each cycle, your vital signs will be measured before and after you receive cetuximab.
Every 6 weeks (+/- 14 days):
- You will have an ECG.
- You will have a CT scan and/or MRI scan to check the status of the disease.
Length of Study:
You may continue to receive treatment as long as you are benefitting. You will be taken off study early if you experience any intolerable side effects, the disease get worse, the doctor thinks it is your best interest, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment and follow-up visits.
End-of-Treatment Visit:
Within 30 days after the last dose of study drugs/placebo, you will have an end-of-treatment visit:
- You will have a physical exam, including measurement of your vital signs and weight
- You will be asked if you have had any side effects and to list any drugs you may be taking.
- Blood (about 3-4 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a CT scan or MRI scan to check the status of the disease.
Long Term Follow-Up:
About every 6 months from then on, you (or your family members or designees) will be asked about how you are doing and what treatments you may be receiving. This may be by phone, letter, email, or during clinic visits.
This is an investigational study. OSI-906 is not FDA approved or commercially available. At this time, OSI-906 is only being used in research. Cetuximab is FDA approved and commercially available for the treatment of colorectal and head/ neck cancer. The combination of OSI-906 and cetuximab is investigational.
Up to 66 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Cetuximab + OSI-906 | Experimental | Drug: Cetuximab, Drug: OSI-906Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + OSI-906 150 mg orally twice a day. 21-Day Cycle. |
| Group B: Cetuximab + Placebo | Experimental | Drug: Cetuximab, Other: PlaceboCetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + Placebo orally twice a day. 21-Day Cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
- Patients must be willing to have a biopsy of tumor tissue for biomarker analysis.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). Measurable lymph nodes are required to be >/= 15 mm in size (short axis diameter). Measurable disease in previously radiated areas is acceptable as long as there has been documented progression.
- Patients must have disease progression: 1) After platinum-based chemotherapy for recurrent/metastatic disease OR 2) Within 6 months of receiving definitive platinum-based combined modality therapy.
- Previous treatment with cetuximab is allowed, as long as there has been a period >/= 6 months between the last cetuximab treatment and randomization
Key exclusion criteria (10 listed)
- Patients may not be receiving any other investigational agents with anti-cancer activity.
- Patients with known, untreated brain metastases. Patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed >/= 28 days prior to study entry and if clinical neurologic function is stable.
- History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906 or other agents used in the study.
- QTc interval > 450 msec at baseline.
- Concomitant drugs with a generally accepted risk of causing Torsades de Pointes
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 |
|---|---|---|
| CetuximabAlso: C225, Erbitux, IMC-C225Loading dose 400 mg/m2 by vein once followed by 250 mg/m2 weekly (+/- 7 days). | Drug | Group A: Cetuximab + OSI-906, Group B: Cetuximab + Placebo |
| OSI-906150 mg by mouth twice a day. | Drug | Group A: Cetuximab + OSI-906 |
| PlaceboAlso: sugar pillPlacebo taken by mouth twice daily. | Other | Group B: Cetuximab + Placebo |
Primary outcome
Progression Free Survival (PFS)
Time frame: From treatment initiation to progressive disease or death, up to 24 months for study period.
PFS is time to progressive disease or death of any cause from randomization date, assessed every 6 weeks with a total study period of approximately 24 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- UT MD Anderson WebsiteLink 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.
William N. William Jr., MD principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab and OSI-906 in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center.
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 12 inclusion and 10 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: withdrawn, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression Free Survival (PFS) (time frame: From treatment initiation to progressive disease or death, up to 24 months for study period.). 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 5 Apr 2013.