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

You may be eligible if

• 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