Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nathan Bahary, MD
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects with biopsy-proven potentially resectable or borderline adenocarcinoma of the pancreas as determined by National Comprehensive Cancer Network (NCCN) criteria
Karnofsky performance status of 70-100%
No active second malignancy except for basal cell carcinoma of the skin
Patient has adequate biological parameters as demonstrated by the following blood counts at screening
Absolute neutrophil count (ANC) ≥1.5 × 109/L;
Platelet count ≥100,000/mm3 (100 × 109/L);
Hemoglobin (Hgb) ≥9 g/dL.
Patient has the following blood chemistry levels at Baseline
aspartate aminotransferase (AST) (SGOT), Alanine transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
Total bilirubin ≤ULN
Serum Creatinine ≤ 1.5mg/dl OR calculated creatinine clearance ≥ 50 for those patients with creatinine greater than 1.5
Prothrombin time (PT)within normal limits (WNL). If patient is on warfarin for prophylactic clot presentation for indwelling catheter, Partial PT/PTT may be +/- 15 %
thromboplastin time (PTT) WNL. If patient on warfarin for prophylactic clot presentation for indwelling catheter, PT/PTT may be +/- 15 %
Age \>18 years.
Patient must be able to swallow enteral medications with no requirement for a feeding tube. Patient's must not have intractable nausea or vomiting which prohibits the patient from oral medications
Ability to understand and the willingness to sign a written informed consent document.
You may not be if
Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection.
Subjects who have received chemotherapy within 12 months prior to randomization.
Prior use of radiotherapy or investigational agents for pancreatic cancer.
Any evidence of metastasis to distant organs (liver, lung, peritoneum).
Symptomatic evidence of gastric outlet obstruction
Inability to adhere to study and/or follow-up procedures
History of allergic reactions or hypersensitivity to the study drugs (hydroxychloroquine, gemcitabine, abraxane).
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All females of childbearing potential must have a blood test or urine study within two weeks prior to randomization to rule out pregnancy.
Patients with porphyria are ineligible.
Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations.
Patients requiring the use of enzyme-inducing anti-epileptic medication that includes: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded.
Patients with previously documented macular degeneration or diabetic retinopathy are excluded.
Baseline electrocardiogram (EKG) with corrected QT interval (QTc) \>470 msec (including subjects on medication). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.
Patient with a history of interstitial lung disease, history of slowly progressive dyspnea, sarcoidosis, silicosis, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis
Patient with known active infection with HIV, Hepatitis B or Hepatitis C
Patients requiring use of warfarin for therapeutic purposes.
Clareo Health | Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine
