Clinical Evaluation of the Delivery and Safety of Aerosolized Liposomal 9-Nitro-20(S)-Camptothecin in Patients with Advanced Pulmonary Malignancies

Clinical Cancer Research

Volumn 10, Issue 7, 2004, Pages 2319-2326

  Verschraegen, Claire F ^a,d   Gilbert, Brian E ^b   Loyer, Evelyne ^c   Huaringa, Armando ^c   Walsh, Garrett ^c   Newman, Robert A ^c   Knight, Vernon ^b  

^a UNIVERSITY OF NEW MEXICO   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d UNIVERSITY OF NEW MEXICO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DILAUROYLPHOSPHATIDYLCHOLINE; DNA TOPOISOMERASE INHIBITOR; LIPOSOMAL 9 NITROCAMPTOTHECIN; LIPOSOME; RUBITECAN; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AEROSOL; AGED; ANEMIA; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; COUGHING; DRUG ABSORPTION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG SAFETY; DYSGEUSIA; DYSURIA; EPISTAXIS; FATIGUE; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; LUNG CANCER; MALE; METASTASIS; NAUSEA; NEBULIZATION; NEUTROPENIA; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; REMISSION; SORE THROAT; THROMBOCYTOPENIA; UTERUS CANCER; VOMITING; WHEEZING;

ADMINISTRATION, INHALATION; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CAMPTOTHECIN; COHORT STUDIES; DNA TOPOISOMERASES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HUMANS; LIPOSOMES; LIVER NEOPLASMS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; TIME FACTORS;

EID: 1842479077     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-0929-3     Document Type: Article

References (17)

1. Ramsey BW, Dorkin HL, Eisenberg JD, et al. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med 1993;328:740-6.
2. Skyler JS, Cefalu WT, Kourides IA, et al. Efficacy of inhaled human insulin in type I diabetes mellitus: a randomised proof-of-concept study. Lancet 2001;357:331-5.
3. Gilbert BE, Knight C, Alvarez FG, et al. Tolerance of volunteers to cyclosporine A-dilauroylphosphatidylcholine liposome aerosol. Am J Respir Crit Care Med 1997;156:1789-93.
4. Gilbert B, Seryshev A, Knight V, Brayton C. 9-Nitrocamptothecin liposome aerosol: lack of subacute toxicity in dogs. Inhal Toxicol 2001;14:185-97.
5. Knight V, Koshkina NV, Waldrep JC, Giovanella BC, Gilbert BE. Anticancer effect of 9-nitrocamptothecin liposome aerosol on human cancer xenografts in nude mice. Cancer Chemother Pharmacol 1999; 44:177-86.
6. Koshkina NV, Gilbert BE, Waldrep JC, Seryshev A, Knight V. Distribution of camptothecin after delivery as a liposome aerosol or following intramuscular injection in mice. Cancer Chemother Pharmacol 1999;44:187-92.
7. Blaney SM, Takimoto C, Murry DJ, et al. Plasma and cerebrospinal fluid pharmacokinetics of 9-aminocamptothecin (9-AC), irinotecan (CPT-11), and SN-38 in nonhuman primates. Cancer Chemother Pharmacol 1998;41:464-8.
8. Knight V, Kleinerman ES, Waldrep JC, Giovanella BC, Gilbert BE, Koshkina NV. 9-Nitrocamptothecin liposome aerosol treatment of human cancer subcutaneous xenografts and pulmonary cancer metastases in mice. Ann NY Acad Sci 2000;922:151-63.
9. Phalen, A. Inhalation studies: foundations and techniques. Baton Rouge, FL: CRS Press, 1984.
10. Knudson R, Lebowitz M, Holberg C. Changes in the normal maximal expiratory flow-volume curve with growth and aging. Am Rev Respir Dis 1983;127:725-34.
11. Miller A, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-14.
12. Verschraegen CF, Gilbert BE, Huaringa AJ, et al. Feasibility, Phase I, and pharmacological study of aerosolized liposomal 9-nitro-20(S)-camptothecin in patients with advanced malignancies in the lungs. Ann NY Acad Sci 2000;922:352-4.
13. Zamboni W, Jung L, Jin R, et al. Phase I & pharmacokinetic (PK) study of intermittently administered 9-nitrocampothecin (9NC, Rubitecan) in patients with advanced malignancies. Proc Am Soc Clin Oncol 2001;20:A411.
14. Verschraegen CF, Natelson EA, Giovanella BC, et al. A Phase I clinical and pharmacological study of oral 9-nitrocamptothecin, a novel water-insoluble topoisomerase I inhibitor. Anticancer Drugs 1998;9:36-44.
15. Zamboni WC, Jung LL, Egorin MJ, et al. Phase I studies of intermittently administered 9-nitrocamptothecin (9NC): relationship between daily dose and toxicity. Proc Am Soc Clin Oncol 2002;21:A390.
16. Verschraegen CF, Gupta E, Loyer E, et al. A Phase II clinical and pharmacological study of oral 9-nitrocamptothecin in patients with refractory epithelial ovarian, tubal or peritoneal cancer. Anticancer Drugs 1999;10:375-83.
17. Pastorino U, Grunenwald D. Pulmonary metastases. In: Pearson FG, editor. Thoracic surgery. Philadelphia: Churchill Livingstone. 2000; p. 962-973.