This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: January 12, 2011
Last updated: April 30, 2013
Last verified: April 2013
The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells.
||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||March 2015 (Final data collection date for primary outcome measure)
Experimental: Intraoperative Gemcitabine
1000mg/m2 IV, single intraoperative infusion.
During surgery, before removal of pancreas, intravenous (IV) dose of 500mg/m2 at a fixed dose rate of 10mg/m2/min for first 2 patients to validate hematologic safety. All subsequent patients receive 1000mg/m2 at similar rate.
500mg/m2 per vein at a fixed dose rate of 10mg/m2/min
- Gemcitabine Hydrochloride
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients with Islet cell tumors are not eligible.
- Patients do not have known metastases.
- 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.
- Patients with a Karnofsky performance status greater than 70 are eligible.
- 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.
- 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.
- 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.
- 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.
- 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.
- Patients must sign a study-specific consent form.
- Patient has received preoperative chemotherapy and/or radiation.
- Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia.
- Identification of metastatic disease.
- Inability to comply with study and/or follow-up procedures.
- Patients < 18 years of age.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276613
|Contact: Jason B. Fleming, MD
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Jason B Fleming, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 12, 2011
||April 30, 2013
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Resectable Adenocarcinoma of the Pancreas
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs