Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors

Inclusion Criteria

* Must be at least 18 years of age;
* Life expectancy: At least 3 months;
* Performance status: ECOG of 0 or 1;
* Histologic or cytologic proof of a solid tumor cancer that is not amenable to curative surgical resection;
* Evaluable or measurable disease documented within 4 weeks of the start of treatment;
* Prior chemotherapy or radiotherapy is allowed if 4 weeks or more have elapsed prior to starting treatment and patients have recovered from toxicities of prior treatment;
* Adequate organ function:

Hematopoietic: ANC = 1500/ul or more, Platelets = 100,000/ul or more, Hemoglobin = 9.5 g/dL or more, transfusion prior to evaluation is allowed; Hepatic: Bilirubin = 2.0 mg/dL or less and SGPT(ALT) and SGOT(AST) \< 3 x upper limit of normal (\< 5 x upper limit of normal if liver metastases present) Renal: Serum Creatinine \< 2.0 mg/dL;

* Patient has the initiative, geographic proximity, and means to be compliant with the protocol;
* Fertile patients (male or female) must agree to use effective contraception;
* Must be able to swallow and retain tablets.

Exclusion Criteria

* Major surgery within the four weeks preceding the start of treatment;
* Serious medical or psychiatric illness that would prevent self-determined informed consent;
* Intensive chemotherapy treatment;
* Infection or antibiotics at the time of screening;
* Uncontrolled cardiovascular, pulmonary, renal, neurologic, psychiatric, or hepatic dysfunction;
* Pregnant or nursing;
* Pre-existing diarrhea or uncontrolled clinically significant illness other than cancer (i.e. ulcerative colitis, malabsorption syndrome);
* Brain metastases that have not been stable for more than 3 months;
* Known Dihydropyrimidine Dehydrogenase (DPD) deficiency.