| Eligibility |
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed advanced pancreatic
adenocarcinoma that is unresectable or metastatic.
- Patients must have received at least one prior chemotherapy regimen for unresectable/
metastatic disease. There is no limit to number of prior regimens. Prior erlotinib
therapy is allowed.
- Minimum of two weeks since any major surgery, completion of radiation, or completion
of all prior systemic anticancer therapy. Patients must have recovered from the acute
toxicities of any prior therapy to NIH-NCI Common Terminology Criteria for Adverse
Events (CTCAE) Version 3.0 </= Grade 1.
- Age >/= 18 years. Because no dosing or adverse event data are currently available on
the use of erlotinib administered in combination with RAD001 in patients < 18 years of
age, children are excluded from this study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients must have at least one measurable site of disease according to Response
Evaluation Criteria In Solid Tumors (RECIST). This site must be outside a radiation
field.
- Adequate hematologic, hepatic and renal parameters: leukocytes =/>3,000/ul, absolute
neutrophil count =/>1,500/ul, platelets =/>100,000/ul, hemoglobin =/>9g/dL, total
bilirubin </= 1.5 mg/dl, aspartate aminotransferase (AST) </=230 and alanine
aminotransferase (ALT) </=280 IU/L for subjects with documented liver metastases; AST
</=115 and ALT </=140 IU/L for subjects without evidence of liver metastases,
creatinine </=1.5 mg/dl in males, </= 1.2 mg/dl in females.
- Women of childbearing potential (WOCBP) and men must agree to use adequate
contraception prior to study entry for the duration of study treatment and 30 days
after the end of treatment. WOCBP is defined as a woman who has not been naturally
postmenopausal for at least 12 consecutive months or no previous surgical
sterilization. Oral, implantable, or injectable contraceptives may be affected by
cytochrome P450 interactions and are therefore not considered effective for this
study. WOCBP must provide a negative pregnancy test (serum or urine) within 7 days
prior to treatment.
- (Continuation of # 8) Acceptable contraception includes double-barrier methods (any
double combination of: male or female condom with spermicidal gel, diaphragm, sponge,
cervical cap, IUD).
- Signed written informed consent document. Written informed consent must be obtained
prior to any evaluations being performed solely for the purposes of screening for
eligibility for this study.
Exclusion Criteria:
- Prior treatment with any investigational drug within the preceding 2 weeks
- Chronic treatment with systemic steroids or another immunosuppressive agent. Patients
can not receive immunization with attenuated live vaccines within one week of study
entry or during study period
- Limits for fasting lipids must be: cholesterol </= 300mg/dL and triglyceride </= 2.5
times upper limits of normal (ULN). Patients may be allowed to enroll on the trial
after initiation of lipid lowering agents
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies
are not required if the patient does not have a history of brain metastases and has no
neurological signs or symptoms)
- Other malignancies within the past 3 years except for adequately treated carcinoma of
the cervix or basal or squamous cell carcinomas of the skin
- 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; severely
impaired lung function (oxygen dependent, Common Terminology Criteria (CTC) Grade 3 or
4 dyspnea); uncontrolled diabetes as defined by fasting serum glucose >1.5 times ULN;
any active (acute or chronic) or uncontrolled infection / disorders
- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study such as: nonmalignant
medical illnesses that are uncontrolled or whose control may be jeopardized by the
treatment with the study therapy ; liver disease such as cirrhosis, known chronic
active hepatitis or chronic persistent hepatitis; A known history of HIV
seropositivity
- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study such as: Impairment of
gastrointestinal function or gastrointestinal disease that may significantly alter the
absorption of RAD001 and/or erlotinib (e.g., ulcerative disease, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- Patients with an active, bleeding diathesis (if coumarin is used, weekly monitoring is
recommended)
- 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
must have a negative urine or serum pregnancy test within 7 days prior to
administration of RAD001). Oral, implantable, or injectable contraceptives may be
affected by cytochrome P450 interactions, and are therefore not considered effective
for this study. Acceptable contraception includes double-barrier methods (any double
combination of: male or female condom with spermicidal gel, diaphragm, sponge,
cervical cap, intrauterine device [IUD]).
- Patients who have received prior treatment with an mTor inhibitor
- Patients with a known hypersensitivity to erlotinib, RAD001 (everolimus) or other
rapamycins (sirolimus, temsirolimus) or to its excipients
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