Urothelial cancer
Conditions
Interventions
gemcitabine/paclitaxel combination therapy
gemcitabine monotherapy
Sponsors
Teikyo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Urothelial cancer was (must be) confirmed by histological or cytological methods. 2. Locally advanced (T4b, N1-3) or metastatic urothelial cancer who are not eligible for radical surgery 3. Patients had measurable diseases. 4. Regardless of the objectives, CDDP-resistant urothelial cancer. 5. PS 0-2 6. Prior chemotherapy with gemcitabine or paclitaxel was not allowed. 7. major organ function were maintained
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the response rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy | — |
Countries
Japan
Outcome results
None listed