Blase - AB 28/04 - CESAR An dieser Studie nehmen zur Zeit 108 Patienten in insgesamt 16 Kliniken teil.
Titel der Studie
OFFENE, RANDOMISIERTE PHASE-II-STUDIE ZUR UNTERSUCHUNG VON GEMCITABIN PLUS CISPLATIN +/- GLEICHZEITIGER ODER SEQUENTIELLER BEHANDLUNG MIT ZD1839 BEI PATIENTEN MIT FORTGESCHRITTENEM ODER METASTASIERTEM ÜBERGANGSZELLKARZINOM DES UROTHELS - CAESAR
Amendment

Protokoll	Synopsis
P_AB2804.pdf	S_AB2804.pdf

Studienleiter	Ansprechpartner
Herr Prof. Dr. Miller Charité-Universitätsmedizin Berlin Campus Benjamin Franklin 12200 Berlin Hindenburgdamm 30 Tel:030/8445-25 75	Herr Prof. Dr. Miller Charité-Universitätsmedizin Berlin Campus Benjamin Franklin 12200 Berlin Hindenburgdamm 30 Tel:030/8445-25 75

Sponsor	Ansprechpartner Nebenwirkung
astra zeneca	Herr Prof. Dr. Miller Charité-Universitätsmedizin Berlin Campus Benjamin Franklin 12200 Berlin Hindenburgdamm 30 Tel:030/8445-25 75 kurt.miller@charite.de
Status
Abgeschlossen
Phase	Erfor.Gesamtzahl
II	125
AUO eingereicht	AUO Ergebnis
Februar 2004	Empfehlung
DKG eingereicht	DKG Ergebnis
nein
Einschluss	Ausschluss
1. Provision of written informed consent 2. Male or female, aged 18 years or older 3. Histologically? or cytologically-confirmed transitional cell carcinoma of the urothelium 4. Locally advanced or metastatic disease 5. At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumours (RECIST) (see Appendix G) 6. Chemotherapy-naïve 7. WHO performance status (PS) of 0 to 1 8. Life expectancy of at least 3 months 9. Willing and able to comply with the treatment and survival follow-up	1. Previous chemotherapy or other systemic antitumour therapy (e.g. monoclonal antibody therapy) 2. Less than 4 weeks since completion of previous radiotherapy 3. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded). 4. Clinically significant cardiac disease (New York Heart Association Class III or IV; symptomatic coronary artery disease; cardiac arrhythmia not well controlled with medication; myocardial infarction within the last 12 months) 5. Brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation OR previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease 6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 7. Pre-existing neurotoxicity greater than CTC grade 1 8. Incomplete healing from previous oncologic or other surgery 9. Absolute neutrophil count (ANC) less than 1500/mm3, white blood cells (WBC) less than centre-specific normal value, or platelets less than 100 000/mm3 10. Serum bilirubin greater than 1.25 times the centre-specific upper limit of reference range (ULRR) 11. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, hepatic or renal disease) 12. Estimated creatinine clearance (COCKROFT) <60 ml/min 13. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the centre-specific ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases 14. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study 15. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin or St.John’s Wort 16. Hypersensitivity to mannitol, corticosteroids, H2-antagonists and antihistamines 17. Pregnancy or breastfeeding 18. Known ongoing drug or alcohol abuse 19. Known hepatitis B and/or human immunodeficiency virus (HIV) positive blood tests 20. Participation in another study with an investigational drug within 30 days prior to study entry 21. Previous enrolment into this study or another trial with ZD1839 22. Known, severe hypersensitivity to ZD1839 or any of the excipients of this product 23. Known severe hypersensitivity to gemcitabine or cisplatin or any of the excipients of these products
Publiziert Liste
Aktiviert am	Publiziert am
Bericht	Abgeschlossen
Einschluss	Ausschluss