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
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170677

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

No publications provided

Responsible Party: North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier: NCT00170677     History of Changes
Other Study ID Numbers: 4401000
Study First Received: September 13, 2005
Last Updated: May 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014