Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

This study has been completed.

Sponsor:

Information provided by:

North Eastern Germany Society of Gynaecologic Oncology

ClinicalTrials.gov Identifier:

NCT00170625

First received: September 9, 2005

Last updated: August 2, 2011

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

August 2, 2011

Start Date ^ICMJE

June 2004

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Toxicity [ Time Frame: after each cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00170625 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

progression-free survival [ Time Frame: every 3 cycle ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Official Title ^ICMJE

Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

Brief Summary

Compatibility of the topotecan therapy in combination with carboplatin.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Drug: Hycamtin

Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

Study Arm (s)

Not Provided

Publications *

Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. Epub 2009 May 8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age >= 18 years
patient with ovarian cancer after primary therapy
bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl
renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min
liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
ECOG <= 2
Intention of regular follow-up visits for the duration of the study
written informed consent

Exclusion Criteria:

any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
ECOG > 2
patients with radiotherapy within the last 4 weeks

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00170625

Other Study ID Numbers ^ICMJE

310300

Has Data Monitoring Committee

Not Provided

Responsible Party

Prof. Sehouli, Charité Campus Virchow-Klinikum Universitätsmedizin Berlin

Study Sponsor ^ICMJE

North Eastern Germany Society of Gynaecologic Oncology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jalid Sehouli

Charité Campus Virchow Klinikum

Information Provided By

North Eastern Germany Society of Gynaecologic Oncology

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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