Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
Conditions
Interventions
Intervention1: GEMCITABINE AND PACLITAXEL CHEMOTHERAPY PROTOCOL (GEM-PAC): PREMEDITATION:
45 minutes prior to Paclitaxel: DEXAMETHASONE 12 mg IV with ONDANSETRON 16mg in 100 mL NS over 15 minutes.
3
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 years and above 2.ECOG performance status 0,1,2 3.Histologically confirmed advanced urothelial cancer of the urethra, bladder, or upper urinary tracts. 4.Radiologically confirmed unresectable or metastatic disease 5.Estimated GFR less than 60 mL/min as measured by the Cockcroft-Gault method. 6.Left ventricular ejection fraction 40% and above 7.Chemotherapy naïve patients
Exclusion criteria
Exclusion criteria: 1.Brain metastasis 2.End-stage kidney disease requiring haemodialysis 3.New York Heart Association(NYHA)grade III or IV 4.Congestive heart failure, or history of unstable angina/ myocardial infarction within six months prior to study entry 5.Grade 2 or worse peripheral neuropathy 6.Serum SGOT/SGPT levels >5 times the upper normal limits (UNL) provided, Serum Bilirubin (Total) >3 times the UNL. 7.Any acquired immunodeficiency state 8.Presence of second malignancy 9.Pregnant or Lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time defined progresion free survial(T-PFS) will be compared among the patients who are randomized either to Gemcitabine and Carboplatin (GEM-CAR) or Gemcitabine and Paclitaxel (GEM-PAC)chemotherapy after specific treatment intervals.Timepoint: After 4 cycles OF chemo-therapies and after 8 cycles chemo-therapies. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety profile of Gemcitabine and Carboplatin (GEM-CAR)combination chemotherapy with safety profile of Gemcitabine AND Paclitaxel (GEM-PAC)combination chemotherapy among the patients after specific treatment period. Timepoint: After 4 cycles of chemo-therapies and after 8 cycles of chemo-therapies.;To compare the Radiological objective response rate (ORR) of patients in the two arms after specific treatment period.Timepoint: After 4 cycles of chemo-therapies and after 8 cycles of chemo-therapies. | — |
Countries
India
Contacts
Public ContactPARMOD KUMAR
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH
Outcome results
None listed