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

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:	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:

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 [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	194
Study Start Date:	September 2005
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	July 2008 (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

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:	Jalid Sehouli, Prof. Dr. med., Charité-Universitätsmedizin Berlin
ClinicalTrials.gov Identifier:	NCT00170677 History of Changes
Other Study ID Numbers:	4401000
Study First Received:	September 13, 2005
Last Updated:	July 28, 2010
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 February 09, 2012