Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
This trial is active, not recruiting.
|Conditions||distal urethral cancer, proximal urethral cancer, squamous cell carcinoma of the bladder, stage ii bladder cancer, stage iii bladder cancer, urethral cancer associated with invasive bladder cancer|
|Treatments||gemcitabine hydrochloride, cisplatin, therapeutic conventional surgery, laboratory biomarker analysis|
|Sponsor||Fox Chase Cancer Center|
|Start date||May 2012|
|End date||December 2013|
|Trial size||47 participants|
|Trial identifier||NCT01611662, ERP-GU-052, IRB#12-015, NCI-2012-00906|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Pathological complete response rate following chemotherapy before surgery
time frame: Up to 5 years
Male or female participants at least 18 years old.
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
|Official title||Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer|
|Principal investigator||Elizabeth Plimack|
|Description||PRIMARY OBJECTIVES: I. To assess the rate of complete response (pT0) at cystectomy following preoperative dose dense gemcitabine and cisplatin (DD GC) in patients with muscle invasive urothelial carcinoma of the bladder. SECONDARY OBJECTIVES: I. To assess the toxicity profile of DD GC when given in the neoadjuvant setting: To define the number of patients who complete all three cycles of treatment without dose reduction, and to describe the incidence of toxicity. II. To assess the 5 year overall and relapse free survival in patients who receive neoadjuvant DD GC. TERTIARY OBJECTIVES: I. To evaluate tissue specimens from patients to assess for molecular markers that correlate with clinical outcome. OUTLINE: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. After completion of study treatment, patients are followed up for 5 years.|
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