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FBO DAILY ISSUE OF JULY 14, 2002 FBO #0224
SOLICITATION NOTICE

A -- A Phase II Chemoprevention Trial in Familial Adenomatous Polyposis Coli (FAP) Patients?Workstatement No. 65.

Notice Date

7/12/2002
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
 

ZIP Code

20852
 

Solicitation Number

N01-CN-25035-46
 

Response Due

8/26/2002
 

Description

The National Cancer Institute (NCI) intends to negotiate with the University of Texas/MD Anderson Cancer Center, under contract No. N01-CN-95040, to increase the number of patients to be randomized to a Phase II Chemoprevention Trial in Familial Adenomatous Polyposis Coli (FAP) Patients?Workstatement No. 65. The Trial objectives are to determine the relative efficacy and tolerability of two ?active? chemopreventive regimens (e.g., celecoxib + eflornithine vs. celecoxib alone) in colorectal and duodenal cancer risk modulation of FAP patients who have a high risk for cancer in these organs due to a rare inborn mutation in a key tumor suppressor gene. The effects of the drugs will be evaluated by assessing colorectal and duodenal adenoma burdens with regard to several key parameters ? adenoma number, size, histopathologic grade, area of involvement, and global endoscopic assessments ? before and after a six month period of drug administration. In addition, the cellular and molecular effects of the treatment will be evaluated by measurement of a panel of tissue-based biomarkers chosen to reflect: 1) the biochemical effects of the drugs within the target organs of interest (e.g., eicosanoids, ornithine decarboxylase metabolites) and, 2) their downstream effects on potential surrogates of chemopreventive efficacy (e.g., in vivo ACF, proliferation, apoptosis). Data arising from the study will improve our mechanistic insights into the development of cancer in these patients and thereby facilitate future agent identification and development for cancer prevention. Patients are currently being randomized to this trial, however, additional patients are needed to improve the power of the trial to identify important clinical benefits and risks associated with the treatment. Authority: 41 U.S.C. 253(c)(1), as set forth in the FAR 6.302-1. See Numbered Note 22.
 

Place of Performance

Address: University of Texas/MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX

Zip Code: 77030

Country: USA
 

Record

SN00115152-W 20020714/020712213155 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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