Preference Study With Elderly Patients Recurrent Ovarian Cancer

Phase 3

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Treosulfan

• Registration Number: NCT00170690
• Lead Sponsor: North Eastern German Society of Gynaecological Oncology

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Treosulfan	Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
2	Treosulfan	Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc

Primary Outcome Measures

Name	Time	Method
Comparison of patient´s compliance in both arms defined as therapy break-offs	during study treatment

Secondary Outcome Measures

Name	Time	Method
Toxicity, overall survival, progression-free survival	during study treatment and follow-up

Trial Locations

Locations (1)

Charité Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany