Conduct Phase I Clinical Pharmacokinetic studies on specific investigational new drugs sponsored by the Division of Cancer Treatment (DCT), National Cancer Institute (NCI). The Contractor shall provide the parameters and characteristics of drug toxicity, the maximally tolerated dose, and recommend a phase II dose.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Treatment (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CM057738-010
Application #
3613337
Study Section
Project Start
1985-06-01
Project End
1990-04-30
Budget Start
1990-03-01
Budget End
1990-04-30
Support Year
Fiscal Year
1990
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Rowinsky, E K; Long, G S; Noe, D A et al. (1997) Phase I and pharmacological study of CI-980, a novel synthetic antimicrotubule agent. Clin Cancer Res 3:401-7
Rowinsky, E K; Grochow, L B; Sartorius, S E et al. (1996) Phase I and pharmacologic study of high doses of the topoisomerase I inhibitor topotecan with granulocyte colony-stimulating factor in patients with solid tumors. J Clin Oncol 14:1224-35
Francis, P; Rowinsky, E; Schneider, J et al. (1995) Phase I feasibility and pharmacologic study of weekly intraperitoneal paclitaxel: a Gynecologic Oncology Group pilot Study. J Clin Oncol 13:2961-7
Rowinsky, E K; Noe, D A; Grochow, L B et al. (1995) Phase I and pharmacologic studies of pyrazoloacridine, a novel DNA intercalating agent, on single-dosing and multiple-dosing schedules. J Clin Oncol 13:1975-84
Rowinsky, E K; Adjei, A; Donehower, R C et al. (1994) Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia. J Clin Oncol 12:2193-203
Rowinsky, E K; Noe, D A; Ettinger, D S et al. (1993) Phase I and pharmacological study of the pulmonary cytotoxin 4-ipomeanol on a single dose schedule in lung cancer patients: hepatotoxicity is dose limiting in humans. Cancer Res 53:1794-801
Rowinsky, E K; Chaudhry, V; Forastiere, A A et al. (1993) Phase I and pharmacologic study of paclitaxel and cisplatin with granulocyte colony-stimulating factor: neuromuscular toxicity is dose-limiting. J Clin Oncol 11:2010-20
Monsarrat, B; Alvinerie, P; Wright, M et al. (1993) Hepatic metabolism and biliary excretion of Taxol in rats and humans. J Natl Cancer Inst Monogr :39-46
Rowinsky, E K; Conley, B A; Jones, R J et al. (1992) Hexamethylene bisacetamide in myelodysplastic syndrome: effect of five-day exposure to maximal therapeutic concentrations. Leukemia 6:526-34
Grochow, L B; Rowinsky, E K; Johnson, R et al. (1992) Pharmacokinetics and pharmacodynamics of topotecan in patients with advanced cancer. Drug Metab Dispos 20:706-13

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