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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038701
Recruitment Status : Terminated (Slow accrual.)
First Posted : June 5, 2002
Last Update Posted : July 31, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal is to assess survival and patterns of failure in patients treated with Gemzar-based chemoradiation and TNP-470 for locally advanced adenocarcinoma of the pancreas.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: TNP-470 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine-Based Chemoradiation and TNP-470 for Patients With Locally Advanced, Nonmetastatic Adenocarcinoma of the Pancreas
Study Start Date : August 2000
Actual Primary Completion Date : July 2002
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gemzar Chemoradiation + TNP-470 Drug: TNP-470

Primary Outcome Measures :
  1. Patient Survival Rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038701

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Douglas B. Evans, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038701     History of Changes
Other Study ID Numbers: ID98-248
First Posted: June 5, 2002    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Metastatic Pancreas Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents