Preference Study With Elderly Patients Recurrent Ovarian Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

North Eastern Germany Society of Gynaecologic Oncology

ClinicalTrials.gov Identifier:

NCT00170690

First received: September 12, 2005

Last updated: August 2, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

August 2, 2011

Start Date ^ICMJE

August 2004

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of patient´s compliance in both arms defined as therapy break-offs [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00170690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Toxicity, overall survival, progression-free survival [ Time Frame: during study treatment and follow-up ] [ Designated as safety issue: Yes ]

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

Preference Study With Elderly Patients Recurrent Ovarian Cancer

Official Title ^ICMJE

Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös

Brief Summary

Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)

Detailed Description

Approximately 60% of all cancer diseases appear to people aged 65 years and older. Ovarian cancer is the most frequent cause of death among gynaecological malignant tumours. Since the highest carcinoma incidence is between the 60th and 70th year more women will come down with ovarian cancer because of increased life expectancy. At least 65% of patients with FIGO stage III/IV will exhibit a relapse or progress after first-line therapy. In most studies the age of the patients is limited to 65 years. It could be shown that especially elder patients often receive an inadequate operative and cytostatic therapy resulting in a worse prognosis.

Patients aged 70 years or elder who will be treated with treosulfan, given oral or intravenous, shall be compared regarding the patient compliance, toxicity especially hematological and gastrointestinal toxicity grade 3-4 (CTC NCI), overall survival, progression free survival, quality of life.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Drug: Treosulfan
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
Drug: Treosulfan
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc

Study Arm (s)

Experimental: 1
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc

Intervention: Drug: Treosulfan
Experimental: 2
Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc

Intervention: Drug: Treosulfan

Publications *

Not Provided

* 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

Active, not recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patient with relapsed ovarian cancer
study therapy of third regime
measurable or evaluable tumor lesions or progression defined as CA-125 more than >= 100 U/ ml.
Age >= 70 years
ECOG 0-2
written informed consent

Exclusion Criteria:

Pretreatment with treosulfan
patient without measurable or evaluable tumor lesions or CA-125 more than >= 100 U/ ml.
no adequate bone marrow function (leukocyte <= 2,9 x 109/l, platelets <= 100 x 109/ l
creatinin and bilirubin within >= 1,25 x fold of the reference laboratory´s normal range
simultaneous radiotherapy

Gender

Female

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00170690

Other Study ID Numbers ^ICMJE

3401000

Has Data Monitoring Committee

Responsible Party

W. Lichtenegger, Prof. Dr., Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 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

August 2011

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

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