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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170677
• Other study ID #: 4401000
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 13, 2014
• Start date: September 2005
• Est. completion date: January 2013

Study information

• Verified date: July 2010
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Topotecan
Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
• Topotecan
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.

Locations

Country	Name	City	State
Germany	Charité Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of CR and PR in each arm		every 12 weeks	No
Secondary	Toxicity of topotecan treatment		after each cycle	Yes
Secondary	Progression-free survival of both arms		every 12 weeks	No