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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00170677
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 14, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Topotecan Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
Study Start Date : September 2005
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00170677     History of Changes
Other Study ID Numbers: 4401000
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: July 2010

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