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. Exclusion Criteria Patients who have or are: Gilbert syndrome (familial, non-hemolytic, acholuric jaundice). patients with enterostomies. untreated brain metastases or deteriorating neurological function after the completion of cranial irradiation. a woman who is currently pregnant and/or breast-feeding. active infections or any serious systemic disorder that, in the opinion of the principal investigator, are incompatible with the study product and/or procedures. used an investigational agent within 4 weeks of study entry. a known hypersensitivity to the study medication, its excipients, its analogs, or any of the component herbs.