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Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer


The Study Drugs:

RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of
new blood vessels that help tumor growth, which may cause the tumor cells to die.

Erlotinib hydrochloride is designed to block the activity of a protein found on the surface
of many tumor cells that may control tumor growth and survival. This may stop tumors from
growing.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take erlotinib
hydrochloride by mouth every day of each 28-day study "cycle". You should take erlotinib
hydrochloride once a day in the morning with 1 cup (about 8 oz.) of water. Erlotinib
hydrochloride should be taken at least 1 hour before or 2 hours after you have any food,
vitamins, iron supplements, or other non-prescription drugs.

On Days 1, 8, 15, and 22 of each cycle, you will take RAD001 by mouth in the morning. You
should either take the study drug on an empty stomach with 2 cups (about 16 oz.) of water or
after a low-fat meal. You should not take the study drug after large fatty meals because
fatty meals lower the amount of the study drug in your body. Some examples of a low-fat meal
include cereal with fat-free milk, a low-fat muffin, toast, or a bagel with fat-free spread,
or fruit salad.

On days when you take both RAD001 and erlotinib hydrochloride, RAD001 should be taken right
before erlotinib hydrochloride.

If you experience intolerable side effects, you must call your doctor right away. The doctor
may tell you to stop taking the study drugs or to take fewer pills. The study drugs may also
be stopped completely, if your doctor thinks it is necessary.

Study Visits:

On Day 1 of every cycle, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- You will have a performance status evaluation.

- Blood (about 2 tablespoons) and urine will for collected for routine tests. You should
be fasting at the time of the blood draw. You should not eat or drink anything except
water after midnight the night before.

- You will be asked about any drugs you may be taking or have taken since your last
visit.

On Day 8 of Cycle 1, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- Blood (about 2 tablespoons) and urine will be collected for routine tests. You should
be fasting at the time of the blood draw. You should not eat or drink anything except
water after midnight the night before.

- You will be asked about any drugs you may be taking or have taken since your last
visit.

At the end of every even cycle (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan
to check the status of the disease. The scans will be the same type that you had during
screening.

Length of Study:

You may remain on study as long as you are benefitting. You will be taken off study early if
the disease gets worse, you have intolerable side effects, or if your doctor decides that it
is in your best interest to stop treatment.

End-of-Study Visit:

About 14 days after the last dose of study drug, you will have an end-of-study visit. The
following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- You will have a performance status evaluation.

- Blood (about 2-3 tablespoons) and urine will be collected for routine tests. You should
be fasting at the time of the blood draw. You should not eat or drink anything except
water after midnight the night before.

- If you have not had them within the last 4 weeks, you will have a CT or MRI scan to
check the status of the disease. The scans will be the same type that you had during
screening.

Long-Term Follow-Up:

After you go off study, you will be asked how you are doing once a month for the first 6
months from the beginning of the study treatment. Then you will be asked how you are doing
every 3 months from then on. This may be done either by phone contact or a clinic visit and
will take about 15-30 minutes.

This is an investigational study. Erlotinib hydrochloride in combination with gemcitabine
is commercially available and FDA approved for the treatment of pancreatic cancer. RAD001
is not FDA approved or commercially available. At this time, the combination of these drugs
is only being used in research.

Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.


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
- 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 aminotransferase (ALT) creatinine
- 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 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 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants Surviving at 6 Months

Outcome Description:

Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Milind Javle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2007-0666

NCT ID:

NCT00640978

Start Date:

March 2008

Completion Date:

March 2010

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Advanced Pancreatic Cancer
  • Unresectable
  • Metastatic
  • RAD001
  • Everolimus
  • Erlotinib
  • OSI-774
  • Erlotinib Hydrochloride
  • Tarceva
  • Pancreatic Neoplasms

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030