Treosulfan oral versus intravenous in recurrent ovarian cancer. An open-label, randomized, controlled, phase 3-b clinical trial
- Conditions
- C56Malignant neoplasm of ovary
- Registration Number
- DRKS00003943
- Lead Sponsor
- niversitätsklinikum FreiburgFrauenklinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 270
(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
(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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Comparison of the tolerance of the different schemata in regards to other aspects of toxicity of the Common Toxicity Criteria of the NCI.<br>Comparison of response of the different schemata and time until progression.<br>Comparison of the subjective experienced quality of life of the patients (by means of EORTC-QLQC30 standard questionnaire)<br>Survival time<br>