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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Topotecan
Topotecan
Sponsored by
North Eastern German Society of Gynaecological Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Campus Virchow-Klinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Rate of CR and PR in each arm

Secondary Outcome Measures

Toxicity of topotecan treatment
Progression-free survival of both arms

Full Information

First Posted
September 13, 2005
Last Updated
May 13, 2014
Sponsor
North Eastern German Society of Gynaecological Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00170677
Brief Title
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
Official Title
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Eastern German Society of Gynaecological Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
Primary Outcome Measure Information:
Title
Rate of CR and PR in each arm
Time Frame
every 12 weeks
Secondary Outcome Measure Information:
Title
Toxicity of topotecan treatment
Time Frame
after each cycle
Title
Progression-free survival of both arms
Time Frame
every 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Lichtenegger
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13533
Country
Germany

12. IPD Sharing Statement

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

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