C56
Conditions
Interventions
Group 1: treosulfan: Ovastat® capsules 250 mg and Ovastat® 1000 / Ovastat® 5000 dry substance:
Arm A: 7000 mg/m² i.v. on day 1, 29, 57 etc. until detection of progression
Group 2: treosulfan: Ovastat
Sponsors
Universitätsklinikum Freiburg
Frauenklinik
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1)Patients with a recurrence of histologically verified ovarian cancer or extra-ovarian ovarian cancer (2)Patients with recurring ovarian cancer who have already undergone 1st and 2nd line therapy, meaning that this trial is equivalent to a therapy starting at the 3rd line. (3)Two dimensional measurable or evaluable tumor lesion or disease progression, expressed through an increase of the tumor marker Ca 125. A distinct increase of the tumor marker parameter Ca 125 into the pathological range of > 100 U/l can be defined as progression/recurrence. The increase must however be documented as a continuous increase with at least 2 measurements. The increase should be at least 25% compared to the reference value after the preceding chemotherapy. At a Ca 125 level of > 1000 U/l, the trial treatment can be initiated immediately. (4)Age = 18 years (5)Minimum life expectancy 3 Months (6) Karnofsky index > 50 % (7)Patient information and written informed consent of the patient
Exclusion criteria
Exclusion criteria: (1)Previous treatment with treosulfan (2)Second malignancy (except basalioma or in situ cervical cancer) (3)Patients with ascites/pleural effusion without evaluable or measurable tumor lesions or no increased Ca 125. (4)Serious concurrent disease (5)No sufficient pre-therapy bone marrow reserves, defined as: leucocytes = 3,5 x 109/l thrombocytes = 100 x 109/l (6)Creatinine = 1,25 x upper limit of normal (7)Total bilurubin = 1,25 x upper limit of normal (exception: benign conjugation disorders, e.g. Gilberts disease) (8)Participation in another experimental therapy study within the past 4 weeks (9)Concurrent or planned radio therapy (10)Other concurrent or planned anti-neoplastic therapy (11)Pregnancy or refusal of adequate contraception in women of child-bearing age for up to three months after end of therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the tolerance of the different schemata in regards to hemotoxicity and gastro-intestinal toxicity grade 3-4 according to the Common Toxicity Criteria of the NCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the tolerance of the different schemata in regards to other aspects of toxicity of the Common Toxicity Criteria of the NCI. Comparison of response of the different schemata and time until progression. Comparison of the subjective experienced quality of life of the patients (by means of EORTC-QLQC30 standard questionnaire) Survival time | — |
Countries
Germany
Contacts
Public ContactKatrin Plarr
iOMEDICO AG
Outcome results
None listed