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A Phase I Study of Radiation Therapy (IMRT) + RAD001 (Everolimus) + Cisplatin for Patients With Head and Neck Cancer

Phase 1
18 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

A Phase I Study of Radiation Therapy (IMRT) + RAD001 (Everolimus) + Cisplatin for Patients With Head and Neck Cancer

Inclusion Criteria:

- 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

- 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).

Exclusion Criteria:

- 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.

- 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

- 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

- 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).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the phase II recommended dose of oral RAD001 (everolimus) tablets + weekly intravenous cisplatin given concurrently with radiation therapy.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Matthew Fury, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

March 2014

Related Keywords:

  • Head and Neck Cancer
  • RAD001(Everolimus)
  • Cisplatin
  • 08-138
  • Head and Neck Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021