Overview

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