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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT00478361
Run by: M.D. Anderson Cancer Center
People needed: 40
Starts: 2007-04-01
Expected to finish: 2015-06-01
Last updated by the study team: 2020-10-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder, urethra, or upper urinary tract
Mixed TCC and variant histologies (i.e., small cell, squamous cell, adenocarcinoma, or sarcoma) allowed if present in < 50% of the biopsy specimen
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
Measurable disease: may include radiographic detection of metastases in lymph nodes (>= 1.5 cm) or liver or lung (>= 1.0 cm) OR pelvic mass palpable on examination under anesthesia
Creatinine clearance < 60 mL/min; no renal insufficiency that requires hemodialysis; no renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy)
Zubrod performance status 0-2
Platelet count > 100,000/mm\^3
Absolute granulocyte count > 1,500/mm\^3
Bilirubin =< 2.0 mg/dL
Aminotransferases (AST and ALT) =< 2 times upper limit of normal
Left ventricular ejection fraction (LVEF) > 40% OR normal electrocardiogram (EKG or ECG) and no history of cardiac disease
All patients must be evaluated in the Department of Genitourinary Medical Oncology at M. D. Anderson Cancer Center or participating CCOP center prior to signing informed consent.
No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy
Prior intravesicular chemotherapy allowed

You may not qualify if…

No brain metastases
Not pregnant or nursing
No severe or uncontrolled infection
No New York Heart Association class III-IV congestive heart failure, unstable angina, or history of myocardial infarction within the past 6 months
No peripheral neuropathy >= grade 2
No persistently uncontrolled diabetes mellitus
No chronic liver disease
No HIV positivity
No other malignancy except nonmelanoma skin cancer unless disease-free for the past 3 years
No overt psychosis, mental disability, or other condition that would preclude giving informed consent
No known sickle cell disease
No uncontrolled severe hypertension
Renal insufficiency that requires hemodialysis or renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy).

Where it is running

Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield — Springfield, Missouri, United States
University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.