Preference Study With Elderly Patients Recurrent Ovarian Cancer

North Eastern German Society of Gynaecological Oncology

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Treosulfan

Study type: Interventional

Funder types: Other

Identifiers

NCT00170690

3401000

Details and patient eligibility

About

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

Full 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.

Enrollment: 123 patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Treosulfan

Drug: Treosulfan

2

Experimental group

Description:

Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc

Treatment:

Drug: Treosulfan

Drug: Treosulfan