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

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer Read More

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