NIPH Clinical Trials Search

UMIN ID: UMIN000002450

Registered date:01/10/2009

Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUrothelial cancer
Date of first enrollment2009/07/01
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)gemcitabine/paclitaxel combination therapy gemcitabine monotherapy


Primary OutcomeTo compare the response rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. prior chemotherapy with gemcitabine or paclitaxel 2. patients with interstitial pneumoniae and pulmonary fibrosis 3. patients with body fluid with the necessity of drainage or severe edema 4. patients with brain metastasis with the necessity of treatment 5. active double cancer 6. severe or uncontrollable complications 7. patients with allergy to polyoxyethylene castor oil-contain drug (e.g., CDDP) or sclerosing castor oil-contain drug (e.g., injectable vitamins) 8. Not eligible for patients during Pregnancy or Lactation, and with the hope of pregnancy 9. Prior therapy is allowed if this is completed more than 28 days before study entry. 10. Otherwise, patients are judged to be not eligible by the attending doctor.

Related Information


public contact
Address Japan
Affiliation Teikyo University, School of Medicine Department of Urology
scientific contact
Name Shigeo Horie
Address 2-11-1, Kaga, Itabashi-ku Japan
Affiliation Teikyo University, School of Medicine Department of Urology