Clinical trial NCT00077259 (phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: epothilone d
SMILES: [H]\C(=C(\C)[C@]1([H])C\C([H])=C(C)/CCC[C@]([H])(C)[C@]([H])(O)[C@@]([H])(C)C(=O)C(C)(C)[C@@]([H])(O)CC(=O)O1)C1=CSC(C)=N1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the
             colon or rectum

          -  Evidence of at least 1 site of unidimensionally measurable disease by radiography or
             physical examination

          -  Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan
             OR oxaliplatin for advanced or metastatic disease

          -  No known CNS metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Hemoglobin ≥ 9 g/dL

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)

          -  Alkaline phosphatase ≤ 5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No New York Heart Association class III or IV congestive heart failure

          -  No QTc > 450 msec for males or > 470 msec for females

          -  No personal or family history of congenital long QT syndrome

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception

          -  No pre-existing neuropathy grade 2 or greater

          -  No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing
             Cremophor

          -  No infection requiring parenteral or oral anti-infective treatment

          -  No altered mental status or psychiatric condition that would preclude giving informed
             consent

          -  No other medical condition that would preclude study participation

          -  No other malignancy within the past 5 years except cured basal cell skin cancer,
             carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a
             prostate-specific antigen < 2 ng/mL

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent sargramostim (GM-CSF)

          -  No concurrent routine prophylactic use of filgrastim (G-CSF)

        Chemotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since prior chemotherapy and recovered

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  At least 3 weeks since prior radiotherapy and recovered

        Surgery

          -  At least 3 weeks since prior surgery and recovered

        Other

          -  More than 3 weeks since prior investigational agents (therapeutic or diagnostic)

          -  No other concurrent therapy for advanced or metastatic colorectal cancer

          -  No other concurrent investigational drugs