National Cancer Institute, Acquisition Management Branch, TBS, 6120 Executive Blvd, EPS/Rm 603 Bethesda, MD 20892-7220

A -- EARLY THERAPEUTICS DEVELOPMENT WITH PHASE 2 EMPHASIS SOL N01-CM-07003-74 DUE 030200 POC Odessa S. Henderson, Contract Specialist, 301-435-3821 or Richard Hartmann, Contracting Officer, 301-496-8605 WEB: Acquisition Management Branch Current Request for Proposals, http://amb.nci.nih.gov/ncics/rfps_published.asp. E-MAIL: Odessa S. Henderson, oh4o@nih.gov. 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 (3) 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 3 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/ncics/rfps_published.asp 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. No collect calls will be accepted. Posted 11/15/99 (W-SN400632). (0319)

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