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

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: April 25, 2008 History of Changes

Sponsor:	North Eastern Germany Society of Gynaecologic Oncology
Information provided by:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00170677

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

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 [ Designated as safety issue: No ]

Enrollment:	194
Study Start Date:	September 2005
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Topotecan Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.
B: Experimental	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

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:	Charité-Universitätsmedizin Berlin ( Jalid Sehouli, Prof. Dr. med. )
Study ID Numbers:	4401000
Study First Received:	September 13, 2005
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00170677 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Ovarian Diseases

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Topotecan
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009