Last updated: 11/07/2018 00:45:27
An Open-Label, Multicenter, Randomized, Phase III Study of Topotecan HCl as Single Agent, Second-Line Therapy (Administered Intravenously as Five Daily Doses Every 21 Days) Versus Taxol. (Administered as a Three-Hour Infusion Every 21 Days) in Women With Advanced Epithelial Ovarian Carcinoma
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 Topotecan HCl as Single Agent, Second-Line Therapy (Administered Intravenously as Five Daily Doses Every 21 Days) Versus Taxol. (Administered as a Three-Hour Infusion Every 21 Days) in Women With Advanced Epithelial Ovarian Carcinoma
Trial description: An Open-Label, Multicenter, Randomized, Phase III Study of Topotecan HCl as Single Agent, Second-Line Therapy (Administered Intravenously as Five Daily Doses Every 21 Days) Versus Taxol. (Administered as a Three-Hour Infusion Every 21 Days) in Women With Advanced Epithelial Ovarian Carcinoma
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:
Carmichael J, Gordon A, Malfetano J, et.al: Topotecan, a new active drug, vs paclitaxel in advanced epithelial ovarian carcinoma (abst). ASCO Proceedings, May 1996.
Efficacy and safety of topotecan in the treatment of advanced ovarian carcinoma. ten Bokkel Huinink, W., Carmichael, J., Armstrong, D., Gordon, A., and Malfetano, J. Semin Oncol 97; 24(1 Suppl 5):S5-19-S5-25
Final analysis of a phase II1, randomized study of topotecan vs paclitaxel in advanced epithelial ovarian carcinoma : international topotecan study group. A. Gordon, J. Carmichael J. Malfetano M. Gore M. Spaczynski D. Clarke-Pearson VV. Ten Bokkel Huinink K. King J. B. Krebs S. Z. Fields. 34th Annual Meeting of the American Society of Clinical Oncology 5/16/1998 Los Angeles, CA; USA
Gore, M, ten Bokkel Huinink, W, et. al.: Clinical Evidence for Topotecan-Paclitaxel Non-Cross-Resistance in Ovarian Cancer. JCO 19:1893-1900, 2001.
Naman, H, Pujade-Lauraine, E, and Guastalla, J 10th International Meeting of Gynaecological Oncology 4/26/1997 Coimbra; Portugal
Pooled analysis of patients with recurrent ovarian cancer who were treated with topotecan after progression or failure on first- or second-line platinum and paclitaxel. Gordon, A MD, ten Bokkel Huinink, W MD, Gore, M MD, Malmstrom, H MD, Krebs, J B MD, and Fields, S Z MD American Society of Clinical Oncology Annual Meeting American Society of Clinical Oncology (ASCO) 33rd Annual Meeting 5/17/1997 Denver, CO; USA""
Topotecan, a new active drug, versus paclitaxel in advanced epithelial ovarian carcinoma: international topotecan study group trial. Carmichael, J MD, Gordon, A MD, Malfetano, J MD, Gore, M MD, Spaczynski, M MD, Davidson, N MD, Savage, J MD, Clarke-Pearson, D MD, Hudson, I MD, Broom, C MD, and Ten Bokkei Huinink, W MD American Society of Clinical Oncology (ASCO) 32nd Annual Meeting 5/18/1996 Philadelphia, PA; USA"
Topotecan, a new active drug, vs paclitaxel in advanced epithelial ovarian carcinoma: international topotecan study group trial. Heron, J F, Gore, M, Gordon, A, Malfetano, J, Ten Bokkel Huinink, W, Malmstron, H, Vennin, P, Coleman, R, Davidson, N, Bolis, G, Imparato, E, Carmichael, J, spaczynski, M, Savage, J, Clarke-Pearson, D, Hudson, I,
Topotecan, a new active drug, vs paclitaxel in advanced epithelial ovarian carcinoma: international topotecan study group trial. W. ten. Bokkel Huininkl, M. Gore M. Spaczynski J. Carmichael N. Davison . Hudson C. Broom A. Gordon International Topotecan Study Group 21st Congress of the European Society for Medical Oncology 11/1/1996 Vienna; Austria
ten Bokkel Huinink W et al. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J Clin Oncol 1997; 15 (6): 2183-2193
Medical condition
Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
January 1994 to May 1996
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
1996-09-05
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
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