Urothelial Carcinoma
Conditions
Interventions
Albumin Bound Paclitaxel combined with gemcitabine:Albumin Bound Paclitaxel 125 mg/m2, ivgtt, 30 minutes, d1, 8 GEM 1000mg/m2, ivgtt, 30 minutes, d1, 8
Carboplatin combined with gemcitabine (GCa):GEM 1000 mg/m2, ivgtt, 30 minutes, d1, 8, CBP is calculated according to renal function according to AUC=4.5 ivgtt, 120 minutes, d1
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patient greater than 18 years of age; 2. Histologically or cytologically confirmed, locally advanced Stage 4 (T4bN0, anyTN2-3) or metastatic transitional cell cancer of the bladder; including other transitional cell cancers of the urothelium (prostate, urethra, ureter, and renal pelvis); 3. Not previously treated with systemic chemotherapy for metastatic bladder cancer (one regimen of adjuvant or neoadjuvant chemotherapy is permitted). Patients must have a disease-free interval of 6 months after adjuvant therapy; 4. Poor candidates for cisplatin-based chemotherapy based on the presence of >= 1 the following: (1) Glomerular filtration rate of 30-60 ml/min (Cockcroft-Gault formula); (2) ECOG performance status score of 2; (3) Hearing loss (trouble communicating with hearing aids or measured at audiometry of 25 dB at two contiguous frequencies); (4) Other concurrent illness which may make the patient a poor candidate for receiving cisplatin. Note: Enrollment of patients with 2 or more of these criteria should occur only after careful consideration by the treating physician regarding the patient's ability to tolerate combination chemotherapy. 5. At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1) guidelines; 6. Life expectancy of greater than or equal to 3 months; 7. Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1.5 X 10^9/L, hemoglobin greater than or equal to 9.0 g/dL (a hemoglobin less than 9.0 g/dL at Screening is acceptable if it is corrected to greater than or equal to 10.0 g/dL by growth factor or transfusion prior to first dose), and platelet count greater than or equal to 100 X 10^9/L; 8. Patients must have adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of the normal range (ULN), and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 2.5 X ULN (in the case of liver metastases, less than or equal to 5 X ULN). If there are bone metastases, liver-specific alkaline phosphatase may be separated from the total and used to assess liver function instead of total alkaline phosphatase; 9. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment; 10. Females of childbearing potential must have a negative serum pregnancy test at screening; 11. Females may not be breastfeeding; 12. Ability to understand and willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breast-feeding. 2. Presence of brain/ meningeal metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization; 3. CTCAE v.4.0 Grade greater than or equal to 2 peripheral neuropathy; 4. Received an investigational agent, chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within 28 days prior to commencing study treatment, or have not recovered from all treatment-related toxicities to Common Toxicity Criteria (CTC) Grade less than or equal to 1, except for alopecia; 5. Are currently receiving an investigational agent or any other systemic anticancer treatment, including palliative radiotherapy; 6. History of other malignancies except: (1) Adequately treated basal or squamous cell carcinoma of the skin; (2) Curable tumor:Including cervical cancer in situ, and incidentally discovered low risk prostate cancer (T1a, Gleason score <6, PSA <0.5ng/ml), superficial bladder cancer; (3) Other curatively treated solid tumor with no evidence of disease for greater than or equal to 5 years; 7. History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to: (1) Active infection requiring antibiotics within 2 weeks before the study inclusion; (2) Concurrent congestive heart failure NYHA (class III-IV); (3) Unstable angina pectoris, or myocardial infarction within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Safety;Health related quality of life;Biomarker; | — |
Countries
China
Contacts
Public ContactShi Yanxia
Sun Yat-sen University Cancer Center
Outcome results
None listed