Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• • Histologically or cytologically confirmed adenocarcinoma of the pancreas.

• Patients must have locally advanced pancreatic cancer, classified as either low-risk resectable (LR), high-risk resectable (HR) or borderline resectable (BR)

• Age between 18 and 90 years at the time of consent.

• Patients with biliary obstruction must have adequate drainage prior to starting treatment.

• Patients must have ≤ Grade I peripheral neuropathy (CTCAE v 4.0)

• Patients must have ≤ ECOG Performance status 2

• Pretreatment laboratory parameters:

• Absolute granulocyte/neutrophil count (AGC/ANC) ≥ 1.8 thou/mm3

• Platelet count ≥ 100,000/mm3

• Bilirubin < 2 mg/dl

• ALT/SGPT < 10x upper limit of normal

• Creatinine < 3 mg/dl

• Calculated creatinine clearance (via Cockcroft-Gault) > 30 mL/min

• Baseline CA 19-9 levels

• Signed study specific, IRB stamped informed consent

Exclusion Criteria:

• • Evidence of any distant metastasis including peritoneal seeding and/or malignant ascites

• Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment

• Prior treatment for pancreatic cancer

• Active, untreated infection

• Surgical resection of the tumor (not including biopsies)

• Other malignancy (except non-melanoma skin cancer) that has not been disease-free for at least 5 years.

• Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable contraception while on treatment and for at least 3 months thereafter.

• Use of anti-epileptics (drugs such as phenytoin, phenobarbitol and carbamazepine)

• ECG abnormality with the following: QTC >500, left bundle branch block or any other clinically significant finding that would interfere with protocol therapy.

• History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician