Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer

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Brief Title

Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer

Official Title

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

Brief Summary

      The goal of this clinical research study is to learn if the combination of RAD001 and
      erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this
      drug combination will also be studied.

      Primary Objectives:

      -Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001
      in patients who have received previous treatment for advanced pancreatic cancer.

      Secondary Objectives:

        -  Determine the progression-free survival (PFS).

        -  Determine the response rate (RR).
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants Surviving at 6 Months


Condition

Pancreatic Cancer

Intervention

RAD001

Study Arms / Comparison Groups

 Erlotinib + RAD001
Description:  Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

16

Start Date

March 2008

Completion Date

March 2010

Primary Completion Date

March 2010

Eligibility Criteria

        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 /= 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 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Milind Javle, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00640978

Organization ID

2007-0666


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 Novartis

Study Sponsor

Milind Javle, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

June 2012