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

This study has been completed.
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology Identifier:
First received: September 13, 2005
Last updated: May 13, 2014
Last verified: July 2010
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Condition Intervention Phase
Ovarian Cancer
Drug: Topotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Primary Outcome Measures:
  • Rate of CR and PR in each arm [ Time Frame: every 12 weeks ]

Secondary Outcome Measures:
  • Toxicity of topotecan treatment [ Time Frame: after each cycle ]
  • Progression-free survival of both arms [ Time Frame: every 12 weeks ]

Enrollment: 194
Study Start Date: September 2005
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Topotecan
Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
Experimental: B 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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00170677

Charité Campus Virchow-Klinikum
Berlin, Germany, 13533
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Study Chair: Werner Lichtenegger Charite University, Berlin, Germany
  More Information

Responsible Party: North Eastern Germany Society of Gynaecologic Oncology Identifier: NCT00170677     History of Changes
Other Study ID Numbers: 4401000
Study First Received: September 13, 2005
Last Updated: May 13, 2014

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on May 25, 2017