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
- Conditions
- rothelial cancer
- Registration Number
- JPRN-UMIN000002450
- Lead Sponsor
- Teikyo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the response rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy
- Secondary Outcome Measures
Name Time Method