Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

Inclusion Criteria

• •Histologically confirmed solid tumors
• •Advanced colorectal cancer or other adenocarcinomas
• •Tumor progression after standard chemotherapy, or where none yet approved
• •At least one unidimensionally measurable lesion
• •Karnofsky performance \>= 70%
• •Life expectancy of at least 3 months
• •Age \>= 18 years
• •Signed, written Institutional Review Board (IRB)-approved informed consent
• •Acceptable liver function:
• •* Bilirubin \<= 1.5 x upper limit of normal (ULN)
• •* AST (SGOT) and ALT (SGPT) \<= 2.5 x ULN, OR
• •* AST (SGOT) and ALT (SGPT) \<= 5 x ULN if liver metastasis
• •Acceptable renal function:
• •* Serum creatinine within normal limits, OR
• •* Calculated creatinine clearance of \>= 60 mL/min/1.73 m2 for certain patients
• •Acceptable hematologic status:
• •* Absolute neutrophil count (ANC) \>= 1500 cells/mm3
• •* Platelet count \>= 100,000 (plt/mm3)
• •* Hemoglobin \>= 9 g/dL
• •Urinalysis: No clinically significant abnormalities
• •Acceptable coagulation status:
• •* Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
• •* For patients on anticoagulation therapy, status within therapeutic range
• •For men and women of child-producing potential, use of effective contraception
• •Tumors accessible for needle biopsy