Prostata - AP13/95 - Estramustin+Etoposid Keine aktuellen Patienten und Klinikzahlen zu dieser Studie.
Titel der Studie
Therapy Optimization Trial of a Combination of oral Estramustinphosphat (Estracyt ®) and oral Etoposid (Vepesid ®) in Hormone Resistant Metastativ Prostate Cancer (Pharmacia)
Amendment

Protokoll	Synopsis
AP_13_95.pdf

Studienleiter	Ansprechpartner
Herr Prof. Dr. med. Breul Loretto Krankenhaus 79100 Freiburg Mercystr. 6 - 14 Tel:0761/70 84 123 Urologie@rkk-lok.de	nicht angegeben         Tel:

Sponsor	Ansprechpartner Nebenwirkung
astra zeneca	nicht angegeben         Tel:
Status
Abgeschlossen
Phase	Erfor.Gesamtzahl
	40
AUO eingereicht	AUO Ergebnis
	noch nichts vorhanden
DKG eingereicht	DKG Ergebnis
	noch nichts vorhanden
Einschluss	Ausschluss
a) Histologically proven carcinoma of the prostate ( any T or N category ) with evidence of progressive metastatic disease following primary hormonal treatment ( surgical or medical castration ) b) PSA > 100 µg/l or a PSA value between 20 and 100 µg/l if it has increased by at least 100% during the preceding two months c) The serum testosterone within the institution's castration level d) Patients on a medical castration therapy with a LHRH analogue will continue this treatment together with the estramustine phosphate ( Estracyt® ) and etoposide ( Vepesid® ) combination therapy. e) Adequate bone marrow reserve: - white blood cell count 3.0 x 109/l - platelet count 100 x 109/l If a depressed count is considered to be due to tumor invasion of the bone marrow, treatment may be initiated f) Performance status (WHO criteria) 0-2 (cf. Appendix V) g) Patients irrespective of age with a minimum life expectancy of more than 90 days h) Written informed consent prior to trial entry i) Age < 80 years	Previous systemic chemotherapy except primary hormonal manipulation ( orchiectomy, LHRH). One trial with either flutamide of corticosteroids as secondary systemic treatment does not represent an exclusion criterion. If Flutamide was given, the drug should have been discontinued for a least one month prior to protocol entry. Patients receiving local palliative radiotherapy at the time of evaluation for this protocal are regarded as ineligible, but can be entered subsequently upon progression after local radiotherapy. Prior surgery ( total prostatectomy or transurethral resection ) and previous local radiotherapy do not represent exclusion criteria. A second malignancy apart from basal cell carcinoma of the skin. Cardiovascular disorders, i.e., systemic congestive heart failure, stable or nonstable angina pectoris, myocardial infarction or stroke within the previous six months, uncontrolled hypertension or deep vein thrombosis. Inadequate renal ( creatinine 1.5 x upper limits of normal ) or liver (bilirubin 1.5 x upper limits of normal ) function.
Publiziert Liste
Aktiviert am	Publiziert am
Jan. 1998
Bericht	Abgeschlossen
	11. Juli 2003 wg. Patientenmangel
Einschluss	Ausschluss