A Phase ll trial to measure the response rate (Rate of recurrence following treatment) ,toxicity and safety of weekly intravesical gemcitabine in patients with transitional cell carcinoma of the bladder.

St George Hospital, Kogarah0 个研究点目标入组 90 人开始时间: 2007年3月7日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Patients must have either i) newly diagnosed superficial transitional cell carcinoma of the bladder, up to G3cT1, previously untreated by intravesical chemotherapy (Group A), or,ii) recurrent superficial transitional cell carcinoma of the bladder after at least one previous course of intravesical Bacillus Calmette-Guerin (BCG) or Mitomycin (Group B). At least 12 weeks must have elapsed since the last BCG or Mitomycin treatment.• Pathologic or cytologic confirmation of transitional cell carcinoma. • Males or females are eligible Karnofsky Performance Status (KPS) >70% • Adequate marrow function defined as neutrophils > 1.5x109/l and platelets >100 x109/l• Adequate hepatic function defined as total bilirubin < 1.5 x normal and aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 3 times normal• Informed consent.

•Prior radiation to the bladder. Previous radiation to other sites in the pelvis (eg. Prostate) is allowed, provided no more than 25% of the pelvis was included in the radiation (RT) field, and all side effects from RT have resolved.• Muscle invasive disease at baseline cystoscopy• Untreated urinary tract infection or abscess within the previous 7 days• Other concerns that in the opinion of the investigator, would make it difficult or unethical for a patient to undergo intravesical treatment within approximately 6 weeks of baseline cystoscopy

发起方

St George Hospital, Kogarah