Overview

Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas

Status:
Terminated
Trial end date:
2019-04-19
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells, to measure the amount of it that may enter the cells, and for biomarker testing. Biomarkers may be related to participant's reaction to the study drug.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Gemcitabine
Losartan
Pancreatin
Pancrelipase
Criteria
Inclusion Criteria:

1. Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients
with Islet cell tumors are not eligible.

2. Patients do not have known metastases.

3. Patients must have potentially resectable pancreatic cancer and have agreed to undergo
surgical resection at M D Anderson Cancer Center. They will have undergone staging
(physical examination, chest x-ray, contrast enhanced CT or MRI (if CT
contraindicated) and/or angiogram to determine resectability. Potentially resectable
is defined as:No extra-pancreatic disease; No evidence (on CT/MRI) of tumor extension
to the celiac axis or SMA; No evidence (CT/MRI or angiogram) of occlusion of the SMV
or SMPV confluence.

4. Patients with a Karnofsky performance status greater than 70 are eligible.

5. There will be no upper age restriction. Patients less than 18 years of age are
excluded from the protocol because adenocarcinoma of the pancreas is rarely seen in
the pediatric population.

6. Adequate renal, and bone marrow function: Leukocytes >= 3,000/uL; Absolute neutrophil
count >= 1,500/uL; Platelets >= 100,000/Ul; Serum creatinine <= 2.0 mg/dL.

7. Adequate Hepatic function (endoscopic or percutaneous drainage as needed): Total
bilirubin < = 3 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) <=
5 X institutional ULN.

8. Patients must have no fever or evidence of infection or other coexisting medical
condition that would preclude administration of gemcitabine. Patients with
uncontrolled congestive heart failure, unstable angina and myocardial infarction
within 3 months will be excluded.

9. Patient is not pregnant. Women of childbearing potential (defined as those who have
not undergone a hysterectomy or who have not been postmenopausal for at least 24
consecutive months) must agree to practice adequate contraception and to refrain from
breast-feeding, as specified in the informed consent.

10. Patients must sign a study-specific consent form.

Exclusion Criteria:

1. Patient has received preoperative chemotherapy and/or radiation.

2. Major cardiovascular or pulmonary comorbidity that precludes use of general
anesthesia.

3. Identification of metastatic disease.

4. Inability to comply with study and/or follow-up procedures.

5. Patients < 18 years of age.