SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer
Condition: Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IIIA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms; Recurrence
Intervention: ispinesib; laboratory biomarker analysis
Intervention description: Given IV; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying how well SB-715992 works in treating patients with
      advanced or metastatic colorectal cancer. Drugs used in chemotherapy, such as SB-715992, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed advanced/metastatic
             colorectal cancer

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral CT scan

          -  Patients must have received prior therapy (in any setting) with 5-FU, CPT-11, and
             oxaliplatin; patients may have received prior erbitux and bevacizumab, but it is not
             required

          -  Patients must have received at least one prior chemotherapy regimen for advanced
             disease

          -  Tumor must be accessible for biopsy or paraffin embedded tissue must be available for
             review of their biopsy specimen

          -  Life expectancy of > 12 weeks

          -  ECOG performance status 0-2 (Karnofsky >= 50%)

          -  Leukocytes >= 3,000/μL

          -  Absolute neutrophil count >= 1,500/μL

          -  Platelets >= 100,000/μL

          -  Hemoglobin >= 9 mg/dL

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

          -  Creatinine =< 1.5 X institutional upper limit of normal OR creatinine clearance >= 60
             mL/min/1.73 m^2

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from AEs due to agents administered more than 4 weeks earlier

          -  Patients may not have received any other investigational agents within 28 days of
             study entry

          -  Patients may not receive other anti-cancer therapy (cytotoxic, biologic, radiation, or
             hormonal other than for replacement) while on this study

          -  Prohibited medications; SB-715992 is a moderate to significant in vitro inhibitor of
             CYP3A4; the following lists of medications/substances are moderate to significant
             inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may
             alter study drug exposure; the use of these medications/substances within 14 days (> 6
             months for amiodarone) prior to the administration of the first dose of SB-715992
             through discontinuation from the study is prohibited

               -  Inhibitors of CYP3A4:

                    -  Antibiotics: clarithromycin, erythromycin, troleandomycin

                    -  Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day),
                       voriconazole

                    -  Antidepressants: nefazodone, fluovoxamine

                    -  Calcium channel blockers: verapamil, diltiazem

                    -  Miscellaneous: amiodarone*, grapefruit juice, bitter orange

                         -  Use of amiodarone within 6 months prior to the administration of the
                            first dose of SB-715992 is prohibited

               -  Inducers of CYP3A4:

                    -  Anticonvulsants: phenytoin, carbamazepine, Phenobarbital, oxcarbazepine

                    -  Antibiotics: rifampin, rifabutin, rifapentine

                    -  Miscellaneous: St. John's wort, modafinil

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to SB-715992

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with SB-715992

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study