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Result Summary for 104864/090

Result Summary
Protocol ID: 104864/090
Clinical Study ID: 104864/A/090
Official Title: An Open Label, Multicenter, Randomized, Phase III Study of Hycamtin (Topotecan) as Single Agent, Second-Line Therapy (Administered Intravenously as Five Daily Doses Every 21 Days) Versus Second-Line Cyclophosphamide, Doxorubicin and Vincristine (CAV) in Patients with SCLC Who Have Relapsed At Le ...
Phase: Phase 3
Study Indications or Diseases:
  • Lung Cancer, Small Cell
Generic Name: topotecan
Trade/Product Name: hycamtin;hycamtin
Approved Drug Label: http://www.gsk.com/products.html
Results Summary: Click here to download result summary. Click here to download result summary.
Citations:
  • Preliminary results of a randomized comparative phase iii trial of topotecan (t) versus cav as second-line therapy of small cell lung cancer (sclc). Schiller, J H, Von Pawel, J, Clarke, P, Kleisbauer, J P, Dobbs, T, Chrysson, N, Dane, G C, Hudson, I, DeWitte, M, and Fields, S Z 8th World Conference on Lung Cancer 8/10/1997 Dublin; Ireland"
  • Schiller JH, von Pawel J, Clarke P, et al. Preliminary results of a randomized comparative Phase III trial of topotecan (T) versus CAV as second-line therapy of small cell lung cancer (SCLC), Lung Cancer 18, 13, 1997.
  • Preliminary results of a randomised comparative phase 111 trial of topotecan versus cav as second-line therapy of small cell lung cancer. P. Clarke, J. H. Schiller J. Von Pawel j. p. Kleisbauer T. Dobbs N. Chrysson G. Dane 1. Hudson M. DeWitte S. Z. Fields ECCO: 9th European Conference on Clinical Oncology and Cancer Nursing 9/14/1997 Hamburg; Germany
  • Schiller JH, von Pawel J, Shepherd F, et al. Topotecan (T) versus Cyclophoshamide (C) Doxorubicin (A) and Vincristine (V) for the treatment of patients with recurrent small cell lung cancer (SCLC): A Phase III Study. Proc. ASCO 17, 456a, 1998.
  • Independent radiological review of a phase III study of topotecan vs cyclophosphamide, doxorubicin, vincristine for recurrent small cell lung cancer (sclc). S.J. Gwythe , Jl. von Pawel J. P. Kleisbauer J. Schiller P. Clark F. Shepherd G. Ross K. King S. Z. Fields 34th Annual Meeting of the American Society of Clinical Oncology 5/16/1998 Los Angeles, CA; USA
  • Von Pawel J, et.al. Topotecan versus cyclophosphamide, doxorubicin and vincristine for the treatment of recurrent small-cell lung cancer J of Clinical Oncology 17, 658-667 1999
  • Topotecan versus cyclophosphamide, doxorubicin and vincristine for the treatment of patients with recurrent small cell lung cancer (sclc): a phase 111 study. J. Schiller, J. von Pawel F. Shepherd R. Gralla J. P. Kleisbauer P. Clark N. Chrysson A. Depierre D. J. Stewart M. C. Palmer J. Carmichael G. Ross J. B. Krebs S. Z. Fields. 34th Annual Meeting of the American Society of Clinical Oncology 5/16/1998 Los Angeles, CA; USA

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