Last updated: 11/07/2018 00:46:10
An Open, Non-Comparative, Phase II Study of Topotecan Given as a Continuous 21-Day Infusion Every 28 days, to Women with Advanced Epithelial Ovarian Cancer who have failed One Prior Chemotherapy Regimen Containing Cisplatin or Carboplatin
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, Non-Comparative, Phase II Study of Topotecan Given as a Continuous 21-Day Infusion Every 28 days, to Women with Advanced Epithelial Ovarian Cancer who have failed One Prior Chemotherapy Regimen Containing Cisplatin or Carboplatin
Trial description: An Open, Non-Comparative, Phase II Study of Topotecan Given as a Continuous 21-Day Infusion Every 28 days, to Women with Advanced Epithelial Ovarian Cancer who have failed One Prior Chemotherapy Regimen Containing Cisplatin or Carboplatin
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:
Activity of topotecan (tpt) 21-day infusion in platinum-treated ovarian cancer and pharmacodynamics of topol depletion. (a nygog study). H. Hochster, J. Speyer S. Wadlerl C. Runowicz1 R. Wallach R. Oratz A. Chachoua J. Sorich B. Taubes E. Ludwig C. Broom2 21st Congress of the European Society for Medical Oncology 11/1/1996 Vienna; Austria
Gore M; Rustin G; Schuller J; Lane S; Hearn S; Beckman R; Ross G. Topotecan given as a 21-day infusion in the treatment of advanced ovarian cancer. Gore M et al. Br J Cancer, 2001; 84: 1043-1046
Hochster H; Walder S; Runowicz C; Liebes L; Cohen H; Wallach R; Sorich J; Taubes B; Speyer J. Activity and pharmacodynamics of 21-day topotecan infusion in patients with ovarian cancer previously treated with platinum-based chemotherapy. Hochster H et al. J Clin Oncol, 1999; 17 (8): 2553-2561
Pharmacodynamics of 21-day topotecan infusion in a phase ii study of ovarian cancer: correlation with tpt administration and heme toxicity. Hochster, H MD, Liebes, L MD, Jacquotte, A Z MD, Sorich, J Md, Speyer, J MD, Oratz, R MD, Chachoua, A MD, Blum, R MD, Taubee, B MD, Ludwig, E MD, Kim, A MD, Fry, D MD, Broom, C MD, and Potmesil, M MD American Society of Clinical Oncology (ASCO) 32nd Annual Meeting 5/18/1996 Philadelphia, PA; USA"
Phase ii study of topotecan 21-day infusion in platinum-treated ovarian cancer: a highly active regimen: (a nygog study). Hochster, H MD, Speyer, J MD, Wadler, S MD, Runowicz, C MD, Wallach, R MD, Oratz, R MD, Chachoua, A MD, Sorich, J MD, Taubes, B MD, Ludwig, E MD, Broom, C MD, and Blum, R MD American Society of Clinical Oncology (ASCO) 32nd Annual Meeting 5/18/1996 Philadelphia, PA; USA
phase II study of topotecan given as a continuous 21 -day infusion every 28 days in platinum pre-treated ovarian carcinoma. S. Johnsonl, L. Pylel K. King2 M. Gorel ECCO : 9th European Conference on Clinical Oncology and Cancer Nursing 9/14/1997 Hamburg; Germany
Medical condition
Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
June 1994 to August 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
1996-13-08
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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