Preference Study With Elderly Patients Recurrent Ovarian Cancer

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

Detailed Description
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Treosulfan
* Drug: Treosulfan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc | Drug: Treosulfan<br>* Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc<br>|
| Experimental: 2<br>Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc | Drug: Treosulfan<br>* Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of patient´s compliance in both arms defined as therapy break-offs |  | during study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity, overall survival, progression-free survival |  | during study treatment and follow-up |