| Exclusion Criteria: | 1) History of allergies to irinotecan.
2) Known UGT1A1 deficiency with homozygotes.
3) Known history of Gilbert's disease.
4) Patients with greater than grade one diarrhea.
5) Pregnancy or lactation.
6) History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
7) Any serious illness or medical condition: uncontrolled congestive heart failure, uncontrolled hypertension or arrhythmia, active angina pectoris, symptomatic heart disease according to the NYHA class II or greater.
8) Serious uncontrolled active infection.
9) Patients who cannot comply with taking and documenting oral study medications.
10) Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications. PRN medications should also observe this window and follow as closely as possible, but may become a necessity to deviate from the 2 hour window.
11) Patients with uncontrolled brain metastasis.
12) Any chemotherapy, excluding irinotecan alone or in combination with other chemotherapy or biologic agents, within 2 weeks from Day 1 of study treatment initiation.
13) Concurrent radiation therapy.
14) Prior radiation therapy within 4 weeks of treatment initiation. |