NCT00478361

Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function

A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Gemcitabine hydrochloride	Gemcitabine 900 mg/m\^2 IV over 90 minutes repeat every 14 days.
DRUG	Paclitaxel	135 mg/m\^2 IV over 1 hour
DRUG	Doxorubicin hydrochloride	Doxorubicin 40 mg/m\^2 IV over 20 minutes
DRUG	Pegfilgrastim	Subcutaneously injection on day 1.

Timeline

• Start date: 2007-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2007-05-24
• Last updated: 2020-10-09
• Results posted: 2020-10-09

Locations

2 sites across 1 country: United States