| Eligibility |
Inclusion Criteria:
1. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
2. Patients that have failed one platinum-containing chemotherapy regimen with or without
EGFR inhibitor and/or epidermal growth factor receptor (EGFR) inhibitor as systemic
therapy for recurrent/metastatic disease. Prior investigational therapy (with the
exclusion of mammilian target of rapamycin (mTOR) inhibitor) allowed but at least 4
weeks must have elapsed with recovery from all toxicities
3. Patients who had prior induction or concurrent chemotherapy delivered as part of their
primary treatment are eligible as long as they have completed primary therapy at least
6 months prior to study entry.
4. Patients must have at least one measurable site of disease according to Response
Evaluation Criteria in Solid Tumors (RECIST) criteria that has not been previously
irradiated. If the patient has had previous radiation to the marker lesion(s), there
must be evidence of progression since the radiation
5. Age >/= 18 years
6. Minimum of two weeks since any major surgery or completion of radiation. Note:
Patients may have received prior radiation therapy to tumor sites that will not be
assessed for response, unless there is evidence of progression.
7. Completion of all prior systemic anticancer therapy for the treatment of
recurrent/metastatic disease (adequately recovered from the acute toxicities of any
prior therapy) at least 4 weeks prior to study entry
8. Eastern Cooperative Oncology Group (ECOG) performance status </= 2
9. Laboratory Values (within 14 days prior to administration of study drugs): Adequate
bone marrow function as shown by: absolute neutrophil count (ANC) >/= 1.5 * 10^9/L,
Platelets >/= 100 * 10^9/L, Hgb > 10 g/dL; Adequate liver function as shown by: serum
bilirubin </=1.5 * upper limit of normal (ULN), and serum transaminases activity </= 3
* ULN. With the exception of serum transaminases (< 5 * ULN) if the patient has liver
metastases
10. Continued from Inclusion # 9: Fasting serum cholesterol </= 300 mg/dL OR </= 7.75
mmol/L AND fasting triglycerides </= 2.5 * ULN. NOTE: In case one or both of these
thresholds are exceeded, the patient can only be included after initiation of
appropriate lipid lowering medication
11. Signed informed consent
Exclusion Criteria:
1. Prior treatment with any investigational drug within the preceding 4 weeks,
concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy, or therapy
with agents otherwise used in treatment of cancer (for example, methotrexate for
rheumatoid arthritis)
2. Chronic treatment with systemic steroids or another immunosuppressive agent. Steroids
will not be allowed and should be discontinued 24 hours prior to initiation of
treatment on protocol. An exception for replacement steroids prescribed for adrenal
insufficiency will be allowed.
3. Patients should not receive immunization with attenuated live vaccines during study
period or within one week of study entry
4. Patients with metastatic disease to the brain, unless treated and controlled and the
patient is off steroids and/or antiepileptics for at least 3 weeks.
5. Other malignancies within the past 2 years except for adequately treated carcinoma of
the cervix or basal or squamous cell carcinomas of the skin.
6. Patients with active skin, mucosa, ocular or gastrointestinal disorders grade > 1
7. Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study such as: unstable angina
pectoris, symptomatic congestive heart failure, myocardial infarction, </= 6 months
prior to first study treatment, serious uncontrolled cardiac arrhythmia
8. Continued from Exclusion #7: severely impaired lung function; uncontrolled diabetes as
defined by fasting serum glucose >1.5x ULN; any active (acute or chronic) or
uncontrolled infection/ disorders.; nonmalignant medical illnesses that are
uncontrolled or whose control may be jeopardized by the treatment with the study
therapy; liver disease such as cirrhosis, chronic active hepatitis or chronic
persistent hepatitis
9. A known history of HIV or AIDS-related illness or previous seropositivity for the
virus
10. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of study agents (e.g., ulcerative disease,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel
resection).
11. Patients with any condition which impairs the ability to swallow study agent intact
12. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
(except low dose coumarin)
13. Women who are pregnant or breast feeding, or women/men able to conceive and unwilling
to practice an effective method of birth control. (Women of childbearing potential
(WOCP) must have a negative urine or serum pregnancy test within 7 days prior to
administration of study drugs). WOCP: A female of child bearing potential is a
sexually mature woman who: 1) has not undergone a hysterectomy or bilateral
oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive
months (i.e., has had menses at any time in the preceding 24 consecutive months).
14. (Continued from Exclusion # 13) Females must either commit to abstinence from
heterosexual intercourse or use a barrier method of contraception. Oral, implantable,
and injectable contraceptives may be affected by cytochrome P450 interactions, and are
therefore not considered effective for this study. Males must either commit to
abstinence from heterosexual intercourse or use a barrier method of contraception.
15. Lack of resolution of all toxic manifestations of prior chemotherapy biologic therapy
or radiation therapy.
16. Patients who have received prior treatment with an mTor inhibitor.
17. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins
(sirolimus, temsirolimus) or to its excipients
18. Patients with psychiatric illness or confusional status that may impair the patient's
understanding of the informed consent
19. Patients unwilling to or unable to comply with the protocol
20. Patients with any condition which impairs the ability to swallow study agent intact
|
