Gemcitabine Pharmacokinetics

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01276613
First received: January 12, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells.


Condition Intervention
Pancreatic Cancer
Drug: Gemcitabine

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue [ Time Frame: Collection during surgery, patients followed 30 days post surgery ] [ Designated as safety issue: No ]
    Pharmacokinetic (PK) Testing of up to 10 blood samples (about 1 tablespoon each time) drawn during surgery starting before gemcitabine infusion and at end of surgery. Blood samples used to measure levels of gemcitabine in blood at the different time points.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraoperative Gemcitabine
1000mg/m2 IV, single intraoperative infusion.
Drug: Gemcitabine
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.
Other Names:
  • Gemcitabine Hydrochloride
  • Gemzar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276613

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Jason B Fleming, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01276613     History of Changes
Other Study ID Numbers: 2010-0371, NCI-2011-00244
Study First Received: January 12, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Resectable Adenocarcinoma of the Pancreas
Gemcitabine
Gemcitabine Hydrochloride
Gemzar

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gemcitabine
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 23, 2014