Clinical trial NCT00033306 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: ixabepilone, fluoropyrimidine, irinotecan
SMILES: [H][C@]12C[C@H](NC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](C)[C@@H](O)[C@@H](C)CCC[C@@]1(C)O2)C(\C)=C\C1=CSC(C)=N1, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed metastatic colorectal adenocarcinoma

          -  Prior treatment for metastatic disease with at least:

               -  One regimen of irinotecan in combination with a fluoropyrimidine OR

               -  Two regimens comprising fluoropyrimidine-based first-line therapy and
                  irinotecan-based second-line therapy

                    -  May have received cetuximab and/or a fluoropyrimidine as part of second-
                       line therapy

          -  Disease progression during or within 4 months of treatment with irinotecan

          -  At least 1 bidimensionally measurable lesion

          -  No known CNS metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-1

        Life expectancy:

          -  At least 12 weeks

        Hematopoietic:

          -  Absolute neutrophil count at least 2,000/mm^3

          -  Platelet count greater than 125,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present)

        Renal:

          -  Creatinine no greater than 1.5 times ULN

        Cardiovascular:

          -  No New York Heart Association class III or IV heart disease

          -  No history of unstable angina, myocardial infarction, or congestive heart failure
             within the past 6 months

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known prior severe hypersensitivity reactions to agents containing Cremophor EL

          -  No motor or sensory neuropathy grade 2 or greater

          -  No concurrent serious uncontrolled infection or other nonmalignant medical illness

          -  No concurrent psychiatric disorders or other conditions that would preclude study
             compliance

          -  No other active malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Disease Characteristics

          -  No concurrent immunotherapy

          -  No growth factors for 24 hours before and after cytotoxic chemotherapy

        Chemotherapy:

          -  See Disease Characteristics

          -  Additional prior adjuvant or neoadjuvant chemotherapy allowed

          -  At least 4 weeks since prior chemotherapy and recovered

          -  No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease

          -  No prior oxaliplatin

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  No concurrent hormonal therapy except hormone replacement therapy

        Radiotherapy:

          -  At least 3 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy to target lesion unless the lesion has shown progression after
             completion of radiotherapy

          -  No concurrent therapeutic radiotherapy

               -  Focal radiotherapy for palliation of bone symptoms may be allowed

        Surgery:

          -  At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered

        Other:

          -  No other concurrent experimental anticancer medications