EARLY THERAPEUTICS DEVELOPMENT WITH PHASE 2 EMPHASIS:  RFP AVAILABLE 

Release Date:  December 1, 1999

NOTICE:  CA-00-002

National Cancer Institute 

The Cancer Therapy Evaluation Program (CTEP), of the Division of Cancer 
Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking 
organizations or consortia with the capabilities and facilities to provide a 
resource for the conduct of Phase 2 and early clinical trials of NCI-sponsored 
agents, to evaluate biologic effects of these agents on their molecular 
targets, to evaluate other relevant biologic effects and to determine 
clinically relevant outcomes/correlates. Major emphasis shall be on Phase 2 
studies, pilot protocols that explore promising combination therapies, and 
high priority studies that are pivotal for drug development and require rapid 
initiation, completion, and data reporting. NCI staff will notify the 
Contractor of high priority studies as they are identified. The NCI will also 
consider investigator initiated trials for credit under this contract based on 
available resources and priorities. CTEP requires a total resource that will 
provide 800 to 1600 patients accrued to 32 to 64 trials per year. CTEP intends 
to make multiple contract awards. These contracts will require single 
institutions or multi-institutional consortia of clinicians, statisticians, 
data managers, research nurses and others with early phase clinical trial 
expertise with investigational agents in cancer. They must be organized to 
attract adequate patient cohorts for prompt completion of trials. Contractors 
will have flexibility to reform consortial arrangements or subcontract with 
additional sites to meet accrual goals, enhance accrual of unusual patient 
populations, increase accrual rates for high priority trials and/or provide 
biologic/cellular pharmacology expertise for correlative studies. Offerors for 
these contracts must demonstrate that they have expertise in cancer drug 
development, knowledge in the clinical management of specific tumor types, 
Phase 2 clinical trials, pharmacology and pharmacodynamics. They need to 
provide evidence of their own expertise, or access to such expertise, in 
diagnostic and functional imaging, interventional radiology, pathology, and 
other potentially relevant laboratory methodologies. Offerors who propose must 
either 1) document the accrual of at least 100 evaluable adult cancer patients 
to IRB approved Phase 2 trials by the investigators (including all sites in 
the consortium) during a recent 12-month period during the last three years or 
2) document sufficient access to a minimum of 1000 new patients in a recent 
twelve month period to ensure accrual of at least 100 patients per year. 
Offerors must also document the completion and reporting of at least two Phase 
2 trials completed at the offering institution/consortium during 1998-1999. It 
is anticipated that up to eight awards will be made and that the resulting 
contracts will be awarded on an incrementally funded basis for a period of 
three years plus two additional option years. The Standard Industrial 
Classification Code for this acquisition is 8731. RFP N01-CM-07003-74 will be 
available on or about December 3, 1999 with a due date for receipt of 
proposals of March 2, 2000. Copies of the RFP may be obtained at the following 
web site: http://amb.nci.nih.gov/appl/rfp/rfps_published.jsp   It is the 
offeror's responsibility to monitor the above internet site for the release of 
this solicitation and any amendments. POTENTIAL OFFERORS WILL BE RESPONSIBLE 
FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS.  
                         
INQUIRIES

Inquiries regarding this notice should reference RFP N01-CM-07003-74, and 
should be directed to:

 Odessa S. Henderson, Contract Specialist
 TBSS, RCAB, NCI
6120 Executive Boulevard
 Executive Plaza South, Room 603
 Rockville, MD 20852
 Phone 301-435-3821; FAX: 301-402-6699.
Email address:  [email protected]  

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