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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer

Treatments: Drug: Gemcitabine and Cisplatin (DD GC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01589094

12-071

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

51 participants in 1 patient group

Gemcitabine and Cisplatin (DD GC)

Experimental group

Description:

This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.

Treatment:

Drug: Gemcitabine and Cisplatin (DD GC)