Overview

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer

Status:
Terminated
Trial end date:
2019-01-22
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fox Chase Cancer Center
Treatments:
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:

- Patients must have histologically confirmed urothelial carcinoma of the bladder or
urethra; patients with urothelial carcinoma of the prostatic urethra only may be
included at primary investigator (PI) discretion; T-stage must be T2 to T4a; patients
with radiographic N0 disease or N1 disease are eligible for the study; patients must
not have radiographic evidence of metastatic disease; mixed histologies which are
predominantly urothelial, such as with squamous or micropapillary differentiation, are
allowed so long as there is no component of small cell histology; histology must be
confirmed by a pathologist at an institution involved in this study

- Patients must be candidates for radical cystectomy with the goal of cure

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) =<
2.5 X institutional ULN

- Patients must have adequate renal function defined as creatinine clearance >= 50
mL/min; for eligibility, creatinine clearance may be either calculated using the
Cockcroft-Gault formula or measured with 24 hour urine collection; note that 24 hour
urine collection is required at baseline, but does not have to be used for eligibility
if calculated clearance by Cockcroft-Gault is preferred; nephrostomy or ureteral stent
placement in order to achieve adequate creatinine clearance is allowed

- Women of child-bearing potential (WOCBP) and men with a female partner who is a WOCBP
must agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) starting prior to beginning treatment and continuing until at least 3
months after last dose of chemotherapy and surgery; should a woman become pregnant or
suspect she is pregnant while participating in this study or if a female partner of a
man participating in this study becomes pregnant, the treating physician must be
notified immediately; WOCBP must have a negative serum or urine pregnancy test within
7 days prior to initiating study treatment

- No other active malignancy

- Ability to understand and the willingness to sign written informed consent and Health
Insurance Portability and Accountability Act (HIPAA) documents

Exclusion Criteria:

- Patients who have had intravesicular therapy within 4 weeks of study entry, or those
who have not recovered from adverse effects of such agents administered more than 4
weeks earlier

- Patients may not be receiving any investigational agents within 4 weeks of study entry

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gemcitabine or cisplatin or other agents used in the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study

- Known human immunodeficiency virus (HIV)-positive patients on combination
antiretroviral therapy are ineligible

- Patients who have undergone prior radiation to greater than or equal to 25% of the
bone marrow within the past year are excluded

- Patients who have received any previous systemic chemotherapy or radiation therapy for
urothelial carcinoma within 1 year of study entry are ineligible