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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00170677
First received: September 13, 2005
Last updated: May 13, 2014
Last verified: July 2010

September 13, 2005
May 13, 2014
September 2005
January 2013   (final data collection date for primary outcome measure)
Rate of CR and PR in each arm [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00170677 on ClinicalTrials.gov Archive Site
  • Toxicity of topotecan treatment [ Time Frame: after each cycle ] [ Designated as safety issue: Yes ]
  • Progression-free survival of both arms [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • 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.
  • Drug: Topotecan
    Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
  • Active Comparator: A
    Intervention: Drug: Topotecan
  • Experimental: B
    Intervention: Drug: Topotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00170677
4401000
No
North Eastern Germany Society of Gynaecologic Oncology
North Eastern Germany Society of Gynaecologic Oncology
Not Provided
Study Chair: Werner Lichtenegger Charité Campus Virchow Klinikum
North Eastern Germany Society of Gynaecologic Oncology
July 2010

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