Phase 2 N=39 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT00478361 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Oct 2020

Primary outcome: Primary: Objective Response Rate — 56.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Gemcitabine hydrochloride (Drug); Paclitaxel (Drug); Doxorubicin hydrochloride (Drug); Pegfilgrastim (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate	56.4	—
SECONDARY Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease	0.25; 1.09	—
SECONDARY Safety and Efficacy of Same-day Pegfilgrastim	4; 0	—

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.

Eligibility Criteria

Inclusion Criteria

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 = 1.5 cm) or liver or lung (>= 1.0 cm) OR pelvic mass palpable on examination under anesthesia
Creatinine clearance 100,000/mm^3
Absolute granulocyte count > 1,500/mm^3
Bilirubin = 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

Exclusion Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00478361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.