PHASE I CLINICAL TRIALS OF ANTICANCER AGENTS NIH GUIDE, Volume 23, Number 2, January 14, 1994 RFP AVAILABLE: NCI-CM-57208-74 P.T. 34 Keywords: Clinical Trial Chemotherapeutic Agents Pharmacology 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. INQUIRIES 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 .
Return to NIH Guide Main Index
![]() |
Office of Extramural Research (OER) |
![]() |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
![]() |
Department of Health and Human Services (HHS) |
![]() |
||||