Last updated: 11/07/2018 00:46:51
An Open-label, Non-Comparative, Phase II Study of Topotecan as Single Agent, Second-Line Therapy Administered as a Continuous 21-Day Infusion Every 28 Days to Patients with Relapsed or Refractory Small Cell Lung Cancer
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, Non-Comparative, Phase II Study of Topotecan as Single Agent, Second-Line Therapy Administered as a Continuous 21-Day Infusion Every 28 Days to Patients with Relapsed or Refractory Small Cell Lung Cancer
Trial description: An Open-label, Non-Comparative, Phase II Study of Topotecan as Single Agent, Second-Line Therapy Administered as a Continuous 21-Day Infusion Every 28 Days to Patients with Relapsed or Refractory Small Cell Lung Cancer
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:
Evaluation of topotecan (hycamtin) in relapsed small cell lung cancer (sclc). a multicentre phase ii study. Depierre, A, Von Pawel, J, Hans, K, Moro, D, Clark, P, Gatzemeier, U, Paillot, N, Scheithauer, W, Carmichael, J, Santoro, A, and Ross, G 8th World Conference on Lung Cancer 8/10/1997 Dublin; Ireland
Giaccone J. Verweij EORTC Early Clinical Study Lung Cancer Cooperative Group 21st Congress of the European Society for Medical Oncology 11/1/1996 Vienna; Austria
Herben VMM, et.al, Continuous infusion of low-dose topotecan: pharmacokinetics and pharmacodynamics during a phase II study in patients with small cell lung cancer Anti-cancer drugs 9, 411-418 1998
Late phase II trials of topotecan (t) for relapsed small cell lung cancer (sclc). Y. Nishiwakil, S. Negor K. Watanabe M. Fukuoka H. Niitani ECCO: 10th European Cancer Conference - Together with the European Association for Cancer Research (EACR), European Oncology Nursing Society (EONS), European Society for Medical Oncology (ESMO), European Society of Surgical Oncology (ESSO), European So 9/12/1999 Vienna; Austria
Phase ii study of topotecan in refractory and sensitive small cell lung cancer (sclc). Ardizzoni, A, Hansen, H HJ, Dombernowsky, P, Kaplan, S, Postmus, P E, Gamucci, T, Schaefer, B, Wanders, J, and Verweij, J ECCO: 8th European Conference on Clinical Oncology and Cancer Nursing 10/29/1995 Paris; France
Topotecan (hycamtin tm) in small cell lung cancer (sclc) after failure of first line therapy: multicentre phase II study. J. von Pawell, A. Depierrel K. Hansl D. Morol P. Clarkl U. Gatzemeiel N. Paillotl VV. Scheithauerl J. Carmichaell A. Santorol G. Ross2 M. Marangolol ECCO: 9th European Conference on Clinical Oncology and Cancer Nursing 9/14/1997 Hamburg; Germany
Topotecan (t), a new active agent in the second-line treatment of refractory"" and "sensitive" small-cell lung cancer (sclc) . A. Ardizzoni, H. Hansen J. Wanders P. Dombernowsky T. Gamucci S. Kaplan P. Postmus 1. Hudson G."
Topotecan as second-line therapy in patients with small cell lung cancer (sclc): a phase 11 study. J. Eckardt, R. Gralla M. C. Palmer D. Gandara J. Laplante A. Sandler S. Z. Fields D. Fitts C. Broom 21st Congress of the European Society for Medical Oncology 11/1/1996 Vienna; Austria
Topotecan, a new active drug in the second-line treatment of small-cell lung cancer: a phase ii study in patients with refractory and sensitive disease. the european organization for research and treatment of cancer early clinical studies group and new drug development office, and the lung cancer cooperative group. Ardizzoni, A., Hansen, H., Dombernowsky, P., Gamucci, T., Kaplan, S., Postmus, P., Giaccone, G., Schaefer, B., Wanders, J., and Verweij, J. J Clin Oncol 97; 15(5):2090-6
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
July 1994 to May 1996
Type
Not applicable
Phase
2
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
1996-22-05
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website