NIH GUIDE, Volume 23, Number 2, January 14, 1994


P.T. 34


  Clinical Trial 

  Chemotherapeutic Agents 


National Cancer Institute

The Cancer Therapy Evaluation Program (CTEP) of the Division of

Cancer Treatment (DCT), National Cancer Institute (NCI), is seeking

organizations with the capabilities and facilities to provide Phase I

clinical trials of investigational new agents.  Specifically, the

organizations will perform studies to:  (a) define the acute

toxicities of new anticancer agents in patients with advanced cancer;

(b) re-define the acute toxicities and pharmacokinetics of existing

anticancer agents administered in combination with colony stimulating

factors and other toxicity ameliorating agents that may facilitate

the exploration of more effective doses and schedules; (c) provide

information on the pharmacologic characteristics of selected

antitumor agents; (d) define treatment regimens for evaluation of

antitumor activity in Phase II trials; (e) establish appropriate

Phase II doses in special patient populations, such as those with

impaired end-organ function or with heavy pretreatment, geriatric

populations, and to explore pharmacokinetic and pharmacodynamic

differences based on gender, race, or ethnic group; (f) obtain

preliminary information on pharmacokinetic/ pharmacodynamic

correlations that can then be extended in Phase II trials; and (g)

incorporate ancillary basic laboratory studies, when possible and

appropriate, to enhance our understanding of the biochemical and/or

biological mechanisms of drug actions.  The Contractor will accrue at

least 50 contract credits per year to at least three active Phase I

trials per year for five years.  Pharmacokinetics and/or correlative

laboratory studies will be a standard feature of these studies.  All

patients for these studies must be treated at the offeror's own

institution.  Offerors who submit proposals must demonstrate the

accrual of at least 50 evaluable adult cancer patients to IRB

approved Phase I cancer treatment protocol studies conducted at the

offeror's institution during calendar year 1993.

The proposed acquisition is a recompetition of six existing contracts

currently held by the following:  N01-CM-07301, University of

Chicago; N01-CM-07302, Johns Hopkins University; N01-CM-07303,

University of Maryland; N01-CM-07304, Mayo Foundation; N01-CM-07305,

University of Texas Health Science Center, N01-CM-07306, University

of Wisconsin.  It is anticipated that six awards will be made and

that the resulting contracts will be awarded on an incrementally

funded basis for a period of 66 months.


RFP NO. NCI-CM-57208-74 will be issued on or about January 13, 1994

and proposals will be due approximately March 29, 1994.  All

responsible sources may submit a proposal that will be considered by

the NCI.  No collect calls will be accepted.  Requests for this

solicitation must be in writing and reference RFP No. NCI-CM-57208-

74.  Requests are to be addressed and mailed or faxed to:

Odessa S. Henderson

Research Contracts Branch, TCS

National Cancer Institute

Executive Plaza South, Room 603

Bethesda, MD  20892

Telephone:  (301) 496-8620


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