CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Gemcitabine hydrochloride +3 moredrug
Likely dose
Gemcitabine hydrochloride 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00478361
NCT00478361Phase 2Completed
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A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency

M.D. Anderson Cancer Center·interventional·Posted May 24, 2007·Updated Oct 9, 2020

In Brief

A Phase 2 clinical trial evaluating Gemcitabine hydrochloride, Paclitaxel, and 2 other interventions for Distal Urethral Cancer and 10 related conditions. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDistal 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2007
Enrollment StartApr 1, 2007
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 19.1 years ago

Interventions

Gemcitabine hydrochloridedrug

Gemcitabine 900 mg/m\^2 IV over 90 minutes repeat every 14 days.

Paclitaxeldrug

135 mg/m\^2 IV over 1 hour

Doxorubicin hydrochloridedrug

Doxorubicin 40 mg/m\^2 IV over 20 minutes

Pegfilgrastimdrug

Subcutaneously injection on day 1.