Clinical trial · Interventional
Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
NCT01589094CI-TRIAL-00040945completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine and Cisplatin (DD GC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine and Cisplatin (DD GC)
- 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.
- interventionNames
- Drug: Gemcitabine and Cisplatin (DD GC)
Primary outcomes (1)
- measure
- Pathologic Response Rate
- timeFrame
- 1 year
- description
- Defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of lymph node metastases (N0) on the final cystectomy specimen. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDIyer G, Balar AV, Milowsky MI, Bochner BH, Dalbagni G, Donat SM, Herr HW, Huang WC, Taneja SS, Woods M, Ostrovnaya I, Al-Ahmadie H, Arcila ME, Riches JC, Meier A, Bourque C, Shady M, Won H, Rose TL, Kim WY, Kania BE, Boyd ME, Cipolla CK, Regazzi AM, Delbeau D, McCoy AS, Vargas HA, Berger MF, Solit DB, Rosenberg JE, Bajorin DF. Multicenter Prospective Phase II Trial of Neoadjuvant Dose-Dense Gemcitabine Plus Cisplatin in Patients With Muscle-Invasive Bladder Cancer. J Clin Oncol. 2018 Jul 1;36(19):1949-1956. doi: 10.1200/JCO.2017.75.0158. Epub 2018 May 9. PMID 29742009