Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
KangLaiTe USA
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
