Clinical trial NCT00052507 (phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that
             is incurable with conventional therapy

               -  Metastatic or recurrent disease

          -  At least 1 unidimensionally measurable lesion

          -  At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan

          -  Disease must be accessible to biopsy

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1 OR

          -  Karnofsky 70-100%

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Absolute granulocyte count at least 1,500/mm^3

          -  WBC at least 3,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.25 times upper limit of normal (ULN)

          -  AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases
             present)

        Renal

          -  Creatinine no greater than 1.25 times UNL OR

          -  Creatinine clearance at least 50 mL/min

        Cardiovascular

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other uncontrolled concurrent illness

          -  No ongoing or active infection

          -  No other active malignancy within the past 3 years except curatively treated
             nonmelanoma skin cancer or carcinoma in situ of the cervix

          -  No grade 1 or greater peripheral neuropathy due to prior chemotherapy

          -  No significant traumatic injury within the past 21 days

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No more than 1 line of prior chemotherapy (including any combination of fluorouracil,
             irinotecan, and/or oxaliplatin) for metastatic disease

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

          -  Prior adjuvant chemotherapy allowed

          -  No concurrent cytotoxic chemotherapy

        Radiotherapy

          -  More than 4 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy to measurable target lesion unless disease progression has
             occurred after radiotherapy

          -  No concurrent radiotherapy to the sole site of measurable disease

        Surgery

          -  More than 21 days since prior major surgery

        Other

          -  No other concurrent investigational agents

          -  No concurrent combination antiretroviral therapy for HIV-positive patients