Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas - Tabular View

Tracking Information
First Received Date ^ICMJE	June 4, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	August 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas
Official Title ^ICMJE
Brief Summary	To assess survival and patterns of failure in patients treated with Gemzar-based chemoradiation and TNP-470 for locally advanced adenocarcinoma of the pancreas.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Pancreatic Neoplasms
Intervention ^ICMJE	Drug: TNP-470
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	34
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Patients must have cytologic or histologic proof of adenocarcinoma of the pancreas. All patients must be staged with a physical exam and CXR. Patients must have locally advanced disease defined as tumor extension to the celiac axis or SMA, or occlusion of the SMPV confluence (on contrast-enhanced CT). There must be no radiographic evidence of metastatic disease. Patients must have had no prior chemotherapy or irradiation. Patients must have a baseline Karnofsky performance status of at least 60. Patients must have adequate bone marrow reserve platelet count >100,000/mL, hemoglobin>9 g/dL, absolute granulocyte count must be >1,500 cells/mm3,serum creatinine must be <1.6 mg/dL. Serum bilirubin must be less than 5 mg/dL prior to therapy with endoscopic or percutaneous drainage if necessary. Patients must have estimated life expectancy of at least 12 weeks. Patients must be at least 18 years of age. There will be no upper age restriction. Female patients must have had childbearing potential terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, barrier device, or abstinence. Patients cannot have hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation. Before receiving external beam irradiation, patients should be able to maintain adequate oral nutrition (90% to 100% of estimated need of calories and protein) and be free of significant nausea and vomiting. Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or >2/3 of one functioning kidney must be able to be shielded from the radiation beam. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy. Patients must sign an informed consent form
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00038701
Responsible Party
Study ID Numbers ^ICMJE	ID98-248
Study Sponsor ^ICMJE	M.D. Anderson Cancer Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	M.D. Anderson Cancer Center
Verification Date	May 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP