Abstract

This study is being conducted to determine the safety and tolerability of CGS 27023A therapy for stage IIIb and IV non small cell lung cancer (NSCLC) patients in combination with paclitaxel and carboplatin. Pharmocokinetic (PK) parameters will also be determined. This trial will provide preliminary information to determine the feasibility of using CGS27023A in combination with paclitaxel and carboplatin in patients with NSCLC in order to enhance the efficacy achieved with paclitaxel and carboplatin alone as it is used now for this disease. The primary objectives of this study are: 1) to establish safety and tolerability of a recommended dose and schedule of CGS27023A in combination with paclitaxel and carboplatin in stage IIIb and IV NSCLC patients. 2) to establish a maximum tolerated dose (MTD) of CGS27023A in combination with full dose paclitaxel and carboplatin in stage IIIB and IV NSCLC patients if the recommended dose and schedule of CGS27023A is not tolerated. 3) to obtain pharmacokinetic data on paclitaxel, carboplatin and CGS27023A in combination in stage IIIb and IV NSCLC patients. 4) to obtain data on absorption, distribution, metabolism and excretion (ADME) of CGS27023A.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000645-29
Application #
6307063
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
29
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Columbia University (N.Y.)
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032

  Publications

Melhem, Nadine M; Keilp, John G; Porta, Giovanna et al. (2016) Blunted HPA Axis Activity in Suicide Attempters Compared to those at High Risk for Suicidal Behavior. Neuropsychopharmacology 41:1447-56
Dong, Chuanhui; Della-Morte, David; Rundek, Tatjana et al. (2016) Evidence to Maintain the Systolic Blood Pressure Treatment Threshold at 140 mm?Hg for Stroke Prevention: The Northern Manhattan Study. Hypertension 67:520-6
Buckley, Jessie P; Engel, Stephanie M; Braun, Joseph M et al. (2016) Prenatal Phthalate Exposures and Body Mass Index Among 4- to 7-Year-old Children: A Pooled Analysis. Epidemiology 27:449-58
Leung, Vivien; Chiu, Ya-Lin; Kotler, Donald P et al. (2016) Effect of Recombinant Human Growth Hormone and Rosiglitazone for HIV-Associated Abdominal Fat Accumulation on Adiponectin and other Markers of Inflammation. HIV Clin Trials 17:55-62
Rosenbaum, Michael; Leibel, Rudolph L (2016) Models of energy homeostasis in response to maintenance of reduced body weight. Obesity (Silver Spring) 24:1620-9
Garyu, Justin W; Meffre, Eric; Cotsapas, Chris et al. (2016) Progress and challenges for treating Type 1 diabetes. J Autoimmun 71:1-9
Widen, Elizabeth M; Whyatt, Robin M; Hoepner, Lori A et al. (2016) Gestational weight gain and obesity, adiposity and body size in African-American and Dominican children in the Bronx and Northern Manhattan. Matern Child Nutr 12:918-28
Maresca, Michelle M; Hoepner, Lori A; Hassoun, Abeer et al. (2016) Prenatal Exposure to Phthalates and Childhood Body Size in an Urban Cohort. Environ Health Perspect 124:514-20
Tooley, James E; Vudattu, Nalini; Choi, Jinmyung et al. (2016) Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes. Eur J Immunol 46:230-41
Cowell, Whitney J; Lederman, Sally A; Sjödin, Andreas et al. (2015) Prenatal exposure to polybrominated diphenyl ethers and child attention problems at 3-7 years. Neurotoxicol Teratol 52:143-50

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