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

NCT00038701 | Terminated Phase 2

• 1 other identifier: ID98-248
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Keywords

Metastatic Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Patient Survival Rate

  2 years

Study Arms (1)

Gemzar Chemoradiation + TNP-470

EXPERIMENTAL

Drug: TNP-470

Interventions

TNP-470 DRUG

Gemzar Chemoradiation + TNP-470

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

O-(Chloroacetylcarbamoyl)fumagillol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Sesquiterpenes; Terpenes

Study Officials

• Douglas B. Evans, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2002
• First Posted: June 5, 2002
• Study Start: August 1, 1999
• Primary Completion: May 11, 2004
• Study Completion: May 11, 2004
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

US (1)