Last updated: 11/07/2018 00:47:46
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 ...
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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 ...
Trial description: 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 ...
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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
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
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.
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.
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
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
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
April 1995 to December 1997
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1997-03-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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