Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589094
• Other study ID #: 12-071
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes surgery for bladder cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Muscle invasive urothelial carcinoma of the bladder histologically confirmed at MSKCC or participating site ((Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or EUA.)

• Clinical stage T2-T4a N0/X M0 disease

• Medically appropriate candidate for radical cystectomy, as per MSKCC or participating site

• Karnofsky Performance Status = 70%

• Age = 18 years of age

• Required Initial Laboratory Values:

• Absolute Neutrophil Count = 1000 cells/mm3

• Platelets = 100,000 cells/mm3

• Hemoglobin = 9.0g/dL

• Bilirubin = 1.5 the upper limit of normal (ULN) for the institution

• Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x ULN for the institution

• Alkaline phosphatase = 2.5 x ULN for the institution

• Serum creatinine = 1.5 mg/dL

• Estimated glomerular filtration rate = 60 ml/min/1.73m2 using the CKD-EPI equation:

eGFR = 141 x min(Scr/k, 1)a x max(Scr/k, 1)-1.209 x 0.993Age

• x 1.018 [if female] x 1.159 [if black] Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1

• If female of childbearing potential, pregnancy test is negative

Exclusion Criteria:

• Prior systemic chemotherapy (prior intravesical therapy is allowed)

• Prior radiation therapy to the bladder

• Evidence of NYHA functional class III or IV heart disease

• Serious intercurrent medical or psychiatric illness, including serious active infection

• Preexisting sensory grade = 2 neuropathy

• Preexisting grade = 2 hearing loss

• Major surgery or radiation therapy < 4 weeks of starting study treatment

• Concomitant use of any other investigational drugs

• Any of the following within the 6 months prior to study drug administration:

myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack

• Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade = 2

• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection

• Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. QOL, are allowed

• Pregnancy or breast-feeding. Patients must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Gemcitabine and Cisplatin (DD GC)
Patients will receive six cycles of GC administered every 14 days. Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering West Harrison	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University	New York	New York
United States	Memorial Sloan Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York
United States	Memoral Sloan Kettering Cancer Center@Phelps	Sleepy Hollow	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	New York University, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Response Rate	Defined as the absence of muscle invasive carcinoma (	1 year
Secondary	Number of Participants With Toxicity	Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.	1 year
Secondary	2 Year Recurrence Free Survival (RFS) Rate for Responders	Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.	2 years
Secondary	2 Year Recurrence Free Survival (RFS) Rate for Nonresponders	Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.	2 years

External Links

•   Memorial Sloan-Kettering Cancer Center