Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
Distal Urethral Cancer
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Urethral Cancer Associated With Invasive Bladder Cancer
Drug: Gemcitabine hydrochloride
Drug: Doxorubicin hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency|
- Overall response rate (complete and partial response) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]Overall response defined as participants with Complete or Partial Response using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response: Disappearance of all target lesions. Partial Response: At least 30% decrease in sum of longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in sum of longest diameter of target lesions, reference smallest sum longest diameter recorded since treatment started or appearance of 1 or > new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
- Time to progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Time measured in months from the date of protocol registration to disease progression, assessed up to 3 years
- Survival duration [ Time Frame: 3 years ] [ Designated as safety issue: No ]Time measured from the date of protocol registration to death, assessed up to 3 years
- Frequency of neutropenic fever or treatment delay because of neutropenia [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Safety and efficacy of pegfilgrastim administered on the day of chemotherapy measured by the frequency of neutropenic fever or treatment delay because of neutropenia
|Study Start Date:||April 2007|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 min; Doxorubicin 40 mg/m^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
Drug: Gemcitabine hydrochloride
Gemcitabine 900 mg/m^2 IV over 90 minutes repeat every 14 days.
Other Names:Drug: Paclitaxel
135 mg/m^2 IV over 1 hour
Other Names:Drug: Doxorubicin hydrochloride
Doxorubicin 40 mg/m^2 IV over 20 minutes
Other Names:Drug: Pegfilgrastim
Subcutaneously injection on day 1.
I. Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency.
I. Assess the safety and tolerability of this regimen in these patients. II. Determine the median time to progression in patients treated with this regimen.
III. Determine the median survival duration in patients treated with this regimen.
IV. Assess the safety and efficacy of pegfilgrastim in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride intravenous (IV) over 20 minutes, paclitaxel IV over 60 minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478361
|United States, Missouri|
|Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield|
|Springfield, Missouri, United States, 65802|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Lance Pagliaro, MD, BA||M.D. Anderson Cancer Center|