Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer

Inclusion Criteria

• •Patients must:
• •be between 18 and 75 years of age, inclusive, at the time of enrollment.
• •have advanced colorectal carcinoma, which may be either measurable or non-measurable.
• •not have received either CPT-11, FU, or other cytotoxic chemotherapy agents in any setting (including adjuvant) within 1 year prior to screening.
• •have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• •use an effective contraceptive method if the patients are of reproductive potential while enrolled in the study, since the potential effects of the herbs on a developing fetus are unknown.
• •have an estimated life expectancy of at least 20 weeks.
• •provide written informed consent.
• •have adequate organ function as indicated by the following laboratory values; these laboratory values must be obtained within 14 days prior to study enrollment:
• •Bone marrow reserve: absolute granulocyte count (AGC) more than or equal to 1.5 X 10(to the power of 9)/L, platelet count more than or equal to 100 X 10 (to the power of 9)/L, and hemoglobin level more than or equal to 9 g/dL.
• •Hepatic function: serum total bilirubin concentration no greater than 1.5 mg/dL, aspartate transaminase (AST or serum glutamic-oxaloacetic transaminase \[SGOT\]), and alanine transaminase (ALT or serum glutamic-pyruvic transaminase \[SGPT\]) levels no greater than grade 2 toxicity as determined from the NCI-CTC version 2.0.
• •Renal function: serum creatinine level no greater than grade 2 toxicity as determined from the CTC version 2.0.