Gemcitabine Pharmacokinetics
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01276613
First received: January 12, 2011
Last updated: April 30, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2015 (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. 500mg/m2 per vein at a fixed dose rate of 10mg/m2/min Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276613
Contacts
| Contact: Jason B. Fleming, MD | 713-745-0890 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| 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 |
| Study First Received: | January 12, 2011 |
| Last Updated: | April 30, 2013 |
| 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 May 16, 2013