Everolimus in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Previous Therapy

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