Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-Resistant Ovarian Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

April 25, 2008

Start Date ^ICMJE

September 2005

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rate of CR and PR in each arm [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00170677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Toxicity of topotecan treatment [ Time Frame: after each cycle ] [ Designated as safety issue: Yes ]
Progression-free survival of both arms [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-Resistant Ovarian Cancer

Official Title ^ICMJE

Brief Summary

Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Detailed Description

Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Drug: Topotecan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

194

Completion Date

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with histologically-confirmed ovarian cancer
relapse within 6 month after primary therapy
primary therapy with platin and taxan
ECOG 0-2
>= 18 years
leukocytes >= 3.000/ µl
platelet >= 100.000/ µl
neutrophil >= 1.500/ µl
written informed consent

Exclusion Criteria:

earlier topotecan therapy
simultaneous or planned radiotherapy
secondary malignancy

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00170677

Responsible Party

Jalid Sehouli, Prof. Dr. med., Charité-Universitätsmedizin Berlin

Study ID Numbers ^ICMJE

4401000

Study Sponsor ^ICMJE

North Eastern Germany Society of Gynaecologic Oncology

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Werner Lichtenegger

Charité Campus Virchow Klinikum

Information Provided By

North Eastern Germany Society of Gynaecologic Oncology

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP