A Phase I/IIA, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover, Dose Escalation, Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer

Inclusion Criteria

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.