Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

Inclusion criteria

• Must have a life expectancy of at least 84 days (12 weeks)
• Must be ambulatory and have either a Karnofsky performance status of 60 or higher or ECOG performance status of 0, 1 or 2
• Must have histologically confirmed pancreatic cancer, either locally invasive or metastatic, and not amenable to potentially curative resection
• Must have measurable or evaluable target lesions, by RECIST 1.1 criteria
• Must not have previously received chemotherapy for metastatic disease
• If female, must have negative pregnancy test, be at least one year post menopausal, or have undergone surgical sterilization and must be willing to use appropriate birth control measures unless post menopausal or post surgical sterilization
• Must be judged by the Investigator to have the initiative and means to be compliant with the protocol including the return for follow-up visits on schedule
• Must give written informed consent prior to any testing under this protocol
• Must have Hemoglobin > 9 gm/dl, WBC>2 x109/ml, and platelets >100,000/ul
• Must have Alkaline Phosphatase < 2.5 x ULN, ALT < 2.0 x ULN, AST< 2.0 x ULN and bilirubin < 2.0
• Must have stable renal function appropriate for age. A patient must have a serum creatinine of < 1.5mg/dl or a GFR > 60 mL/minute
• Must have a central venous catheter if randomized to the G + K arm of study, or if the patient does not have one, must agree to have one placed if randomized to the G+K arm.

Exclusion criteria

• Patient has a history of cancer within 5 years other than pancreatic cancer (excluding resected non melanoma skin carcinoma
• Patient has active (untreated or still receiving corticosteroids) brain metastases
• Patient has had prior chemotherapy for metastatic disease
• Patient has received prior gemcitabine < 12 months previously
• Patient is currently taking a bile acid sequestrant drug (such as Questran, Colestid or Welchol) or a fibric acid derivative drug (such as Lopid, Tricor, Antara, Lofibra and Trilipix) - Patients with disturbances of lipid metabolism such as pathologic hyperlipidemia (including congenital hypertriglyceridemia or cholesterolemia), lipoid nephrosis, or acute pancreatitis
• Patient has uncontrolled Type 1 or 2 diabetes mellitus
• Patient has another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome (e.g., survival) evaluation of the study drugs
• Patient or physician plans surgical treatment of malignancy, radiation therapy, or biological treatment for cancer including immunotherapy while on study, other than surgical bypass or stent insertion for relief of bile flow blockage
• Patient has a known allergy to soybeans (used in production of Kanglaite Injection) or Job's Tear (source of active ingredient of Kanglaite Injection), or to gemcitabine
• Patient has NYHA congestive heart failure Class II or higher from any cause
• Patient has unstable angina or history of an MI within 12 months
• Patient is pregnant or lactating
• Patient has used or plans to use another investigational agent within four weeks prior to screening through the entire study period including study termination and the follow-up visits.