A Phase II Trial of TPI 287 in Patients Advanced, Unresectable Pancreatic Cancer

Inclusion Criteria:

• Patients must have histological or cytological confirmation of ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
• Patients must have metastatic disease precluding curative surgery
• Patients must have received only one prior systemic anticancer treatment for their advanced disease, which must have included a gemcitabine-based therapeutic regimen for advanced disease
• Patients may have received prior adjuvant therapy for their disease
• Patients must have a Karnofsky performance status ≥ 70 (Appendix I)
• Patients must be ≥ 18 years of age

• Women of childbearing potential (WOCBP):

  • Must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study
  • Must have a negative serum or urine pregnancy test

• Patients must have adequate organ function:

  • Bone marrow reserve as evidenced by: Absolute neutrophil count ≥1,500/uL, Platelet count ≥ 100,000/uL
  • Renal function as evidenced by serum creatinine ≥ 2.0 mg/uL
  • Hepatic function as evidenced by: Serum total bilirubin < 2.0 mg/uL, SGOT/SGPT < 3X ULN for the reference lab (< 5X ULN for patients with known hepatic metastases)
• Patient must have recovered from prior surgery, radiotherapy or other antineoplastic therapy
• Patients or their legal representative must be able to read, understand, and sign the informed consent to participate in the trial

Exclusion Criteria:

• Patients with islet cell tumors, lymphoma, or sarcoma of the pancreas
• Patients with more than one prior treatment for metastatic pancreatic carcinoma
• Patients with current peripheral neuropathy > Grade 1
• Patients receiving any concurrent chemotherapy, radiotherapy, hormonal therapy or immunotherapy
• Patients with serious infection or a life-threatening illness (unrelated to tumor) that is > Grade 2 NCI CTCAE V 3.0), or active, serious infections requiring parental antibiotic therapy within 4 weeks prior to screening
• History of cardiac disease or events according to the New York Health Association (NYHA) assessments. Clinically evident congestive heart failure as defined by NYHA Class 3 or 4 CHF or cardiac arrhythmia, including atrial fibrillation, if not adequately controlled
• Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
• Known HIV or Hepatitis B or C (active, previously treated or both)
• A history of other malignancy (except nonmelanoma skin cancer or carcinoma-in-situ of cervix), unless in CR and not receiving therapy for that disease for a minimum of 5 years
• Patients with known hypersensitivity to any of the components of the drugs to be administered on study
• Patients receiving concurrent investigational therapy (investigational therapy is defined as treatment for which there is currently no regulatory authority-approved indication)