Head and Neck CancerPhase 1NCT00858663
Radiation Therapy (IMRT) + RAD001 (Everolimus) + Cisplatin for Patients With Head and Neck Cancer
A Phase 1 study testing intensity modulated radiation therapy and RAD001 (everolimus) + Cisplatin in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the best doses of RAD001 (everolimus) tablets and cisplatin to give to patients who are receiving radiation therapy for head and neck cancer. 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?
- intensity modulated radiation therapy and RAD001 (everolimus) + Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2013
- Phase
- Phase 1
- 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
- Pathologically confirmed head and neck carcinoma, any histology (other than sarcoma, lymphoma, or melanoma). Patients with thyroid cancer (papillary, follicular, undifferentiated, Hurthle cell, medullary, or anaplastic) may be eligible.
- Patients with cutaneous squamous cell cancer or basal cell cancer arising in the head and neck may be eligible.
- Patients will have either Stage III- IVB unresected disease (Patients with stage II-IV B hypopharynx cancer and patients with Stage IIB - IVB nasopharynx cancer may also be eligible) OR
- Will be status post macroscopically complete resection of disease with one of the following poor risk features in the surgical pathology specimen:
- Malignant involvement of 2 or more regional lymph nodes Extracapsular extension of nodal disease Microscopically involved mucosal margins of resection T3 or T4 pathologic stage (excluding T3N0 laryngeal squamous cell cancer) Perineural involvement Oral cavity or oropharyngeal primaries with nodal disease at levels IV or V
- Age > or = to 18 years
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- Karnofsky performance status > or = to 70%
- Adequate bone marrow function: Absolute neutrophil count > than or = to 1.5 X 109/L, Platelets > or = to 100 x 109/L, Hemoglobin > 10 g/dL.
- Adequate liver function: serum bilirubin < or = to 1.5 X upper limit of normal(ULN), and serum transaminases (alanine aminotransferase, ALT; aspartate aminotransferase, AST) activity < or = to 2.0 X ULN.
- Adequate renal function: serum creatinine within institutional normal limits, or calculated creatinine clearance (by Cockcroft and Gault method) > or = to 45 mL/min for patients with creatinine limits above institutional normal.
- INR < 1.5 or aPTT < 1.5 X upper limits of normal
- For women of child-bearing potential, negative urine or serum pregnancy test within 14 days prior to administration of RAD001.
- Men and women of childbearing potential must be willing to consent to using effective birth control methods while on treatment and for at least 3 months there after.
- The planned radiation therapy treatment dose must meet protocol requirements (Resected tumors/post-operative patients: maximum planned dose 66 Gy. Unresected tumors: maximum planned dose 70 Gy).
Who cannot join
- Any prior radiation therapy for head and neck cancer. Any prior radiation therapy to >25% of the bone marrow. Any prior radiation to whole pelvis and/or brain.
- Patients with unresected squamous cell cancer (SCC) arising in the oral cavity, oropharynx, larynx, or hypopharynx are excluded, unless they at have received at least 2 cycles of induction chemotherapy with a regimen that includes cisplatin or carboplatin. (For patients with unresected head and neck tumors other than SCC of oral cavity, oropharynx, larynx, or hypopharynx, there is no requirement for induction chemotherapy prior to protocol chemoradiation)..
- Therapeutic anticoagulation with coumadin (warfarin)
- Peripheral neuropathy > or = to grade 3, according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
- Hypertriglyceridemia > or = to grade 2 (CTCAE version 3.0).
- Patients who require chronic treatment with steroids ( > prednisone 5 mg/day) or other immunosuppressive agents are excluded. Both cisplatin and RAD001 are immunosuppressive, and chronic steroid use (> prednisone 5 mg/day) or use of other immunosuppressive agents might increase the risk of lethal infection in this setting. Patients on low- dose steroid replacement regimens (< or = to prednisone 5 mg/day) are not excluded, because low dose steroids should not be immunosuppressive.
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- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment. Other concurrent severe and/or uncontrolled medical disease which would compromise participation in the study in the opinion of the investigator (e.g., uncontrolled diabetes, unstable angina, or congestive heart failure - New York Heart Association Class III or IV)
- HIV-positive patients. These patients are at increased risk of lethal infections when treated with marrow suppressive therapy. Additionally, pharmacokinetic interactions between antiretroviral therapy and the study regimen may be problematic for these patients.
- Women who are pregnant or lactating
- Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis. For example, patients with nonmelanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer with no current biochemical (PSA) or radiologic evidence of disease may enroll.
- Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is < or = to 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility.
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during the study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines.
- Liver disease such as cirrhosis or severe hepatic impairment (Childs-Pugh class C).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I Study of Radiation Therapy (IMRT) + RAD001 (Everolimus) + Cisplatin for Patients With Head and Neck Cancer
The purpose of this study is to determine the best doses of RAD001 (everolimus) tablets and cisplatin to give to patients who are receiving radiation therapy for head and neck cancer.
- Conditions
- Head and Neck Cancer
- Being tested
- intensity modulated radiation therapy, RAD001 (everolimus) + Cisplatin
- Keywords
- RAD001(Everolimus), Cisplatin, 08-138
- 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.
intensity modulated radiation therapyRadiation
All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy.
Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme.
Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan.
RAD001 (everolimus) + CisplatinDrug
All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy.
Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme.
Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan.
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation | Experimental | * IMRT, 1 fraction/day, over approximately 33 treatment days
* RAD001 per oral or PEG, per dose escalation scheme (Days 1 - 42)
* Cisplatin IV weekly, per dose escalation scheme (Days 1, 8, 15, 22, 29, 36) Receives: Radiation: intensity modulated radiation therapy; Drug: RAD001 (everolimus) + Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the phase II recommended dose of oral RAD001 (everolimus) tablets + weekly intravenous cisplatin given concurrently with radiation therapy.
Measured: 3 months
Secondary outcomes (3)
To evaluate the safety and tolerability of oral RAD001 + radiation therapy + intravenous cisplatin.
Measured: 3 months
To estimate the incidence of over-expression of eIF4E in surgical margins by immunohistochemistry (IHC).(only for those subjects who undergo primary surgery)
Measured: 3 months
To describe the pharmacokinetics of RAD001 administered by PEG (percutaneous gastrostomy) tube.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2013
- Study completionJul 2013
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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Matthew Fury, MD,PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858663
- Sponsor's protocol ID
- 08-138
- Status last verified
- Jul 2013
- First submitted
- 6 Mar 2009
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Radiation Therapy (IMRT) + RAD001 (Everolimus) + Cisplatin for Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00858663
- Acronym / sponsor ID
- 08-138
- Conditions
- Head and Neck Cancer
- Keywords
- RAD001(Everolimus), Cisplatin, 08-138
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Mar 2009 (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 purpose of this study is to determine the best doses of RAD001 (everolimus) tablets and cisplatin to give to patients who are receiving radiation therapy for head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation | Experimental | Radiation: intensity modulated radiation therapy, Drug: RAD001 (everolimus) + Cisplatin* IMRT, 1 fraction/day, over approximately 33 treatment days * RAD001 per oral or PEG, per dose escalation scheme (Days 1 - 42) * Cisplatin IV weekly, per dose escalation scheme (Days 1, 8, 15, 22, 29, 36) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pathologically confirmed head and neck carcinoma, any histology (other than sarcoma, lymphoma, or melanoma). Patients with thyroid cancer (papillary, follicular, undifferentiated, Hurthle cell, medullary, or anaplastic) may be eligible.
- Patients with cutaneous squamous cell cancer or basal cell cancer arising in the head and neck may be eligible.
- Patients will have either Stage III- IVB unresected disease (Patients with stage II-IV B hypopharynx cancer and patients with Stage IIB - IVB nasopharynx cancer may also be eligible) OR
- Will be status post macroscopically complete resection of disease with one of the following poor risk features in the surgical pathology specimen:
- Malignant involvement of 2 or more regional lymph nodes Extracapsular extension of nodal disease Microscopically involved mucosal margins of resection T3 or T4 pathologic stage (excluding T3N0 laryngeal squamous cell cancer) Perineural involvement Oral cavity or oropharyngeal primaries with nodal disease at levels IV or V
Key exclusion criteria (14 listed)
- Any prior radiation therapy for head and neck cancer. Any prior radiation therapy to >25% of the bone marrow. Any prior radiation to whole pelvis and/or brain.
- Patients with unresected squamous cell cancer (SCC) arising in the oral cavity, oropharynx, larynx, or hypopharynx are excluded, unless they at have received at least 2 cycles of induction chemotherapy with a regimen that includes cisplatin or carboplatin. (For patients with unresected head and neck tumors other than SCC of oral cavity, oropharynx, larynx, or hypopharynx, there is no requirement for induction chemotherapy prior to protocol chemoradiation)..
- Therapeutic anticoagulation with coumadin (warfarin)
- Peripheral neuropathy > or = to grade 3, according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
- Hypertriglyceridemia > or = to grade 2 (CTCAE version 3.0).
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 |
|---|---|---|
| intensity modulated radiation therapyAll patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy. Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme. Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan. | Radiation | Chemoradiation |
| RAD001 (everolimus) + CisplatinAll patients will receive standard treatment with definitive radiation therapy (IMRT, intensity modulated radiation therapy), administered as one fraction per day (Monday through Friday) over approximately 33 fractions. Patients with resected tumors will be treated to a maximum dose of 66 Gy. Patients with unresected tumors will be treated to a maximum dose of 70 Gy. Patients will receive daily RAD0001 it will be administered orally or via percutaneous gastrostomy tube (PEG) once daily according to the dose escalation scheme plus cisplatin intravenously once per week (Days 1, 8, 15, 22, 29, 36) according to the dose escalation scheme. Approximately 3 - 4 months after completion of chemoradiation, radiologic response assessment will be performed. This will include cross-sectional imaging of the primary tumor (with CT scan and/or MRI) as well as a whole body FDG-PET (fluorodeoxyglucose positron emission tomography) scan. | Drug | Chemoradiation |
Primary outcome
To establish the phase II recommended dose of oral RAD001 (everolimus) tablets + weekly intravenous cisplatin given concurrently with radiation therapy.
Time frame: 3 months
3 secondary outcomes
To evaluate the safety and tolerability of oral RAD001 + radiation therapy + intravenous cisplatin.
Time frame: 3 months
To estimate the incidence of over-expression of eIF4E in surgical margins by immunohistochemistry (IHC).(only for those subjects who undergo primary surgery)
Time frame: 3 months
To describe the pharmacokinetics of RAD001 administered by PEG (percutaneous gastrostomy) tube.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intensity modulated radiation therapy and RAD001 (everolimus) + Cisplatin in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer 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 14 inclusion and 14 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 25 Jul 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To establish the phase II recommended dose of oral RAD001 (everolimus) tablets + weekly intravenous cisplatin given concurrently with radiation therapy. (time frame: 3 months). 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 25 Jul 2013.