Clinical trial NCT00390364 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: everolimus
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    withdrawn due to low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Cytologically or pathologically confirmed colorectal adenocarcinoma

               -  Advanced or metastatic disease

          -  Refractory to ≥ 1 line of prior therapy

               -  Not amenable to potentially curative surgical resection

          -  Mutations in the PI3K gene in tumor tissue

          -  Tumor tissue available for genetic testing OR willing to undergo baseline tumor biopsy

               -  Tumor amenable to sequential biopsies

               -  Willing to undergo 2 sequential tumor biopsies, and 2 sequential skin biopsies

          -  Measurable lesion with ≥ 1 diameter ≥ 2 cm by conventional CT scan (1 cm by spiral CT
             scan) in a nonirradiated area

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

          -  Life expectancy > 12 weeks

          -  WBC ≥ 3,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin normal

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Cholesterol and triglycerides ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to everolimus

          -  No uncontrolled intercurrent illness, including, but not limited to, any of the
             following:

               -  Hypertension

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situation that would preclude study compliance

          -  No evidence of bleeding diathesis

          -  Able to swallow tablets

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or
             mitomycin C) and recovered

          -  No prior targeted therapy against mTOR

          -  No other concurrent investigational agents

          -  No concurrent therapeutic anticoagulation

               -  Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial
                  access devices allowed provided the requirements for PT, INR or PTT are met.

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent anticancer therapy, including chemotherapy, hormonal therapy,
             immunotherapy, alternative therapy, or radiotherapy

          -  No concurrent live vaccination