NCT01801644

Brief Summary

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

5.8 years

First QC Date

February 15, 2013

Last Update Submit

February 28, 2013

Conditions

Bladder Cancer

Keywords

bladder cancerneoadjuvant chemotherapygem/cis

Outcome Measures

Primary Outcomes (1)

  • pathologic response rate

    evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy

    at time of surgery

Secondary Outcomes (1)

  • safety, number of participants with adverse events and grade of adverse events

    adverse events will be evaluated after every 6 months

Other Outcomes (1)

  • progression free survival (PFS)

    up to 5 years after including the last patient

Study Arms (1)

gemcitabine plus cisplatin

EXPERIMENTAL

gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied

Drug: gemcitabine plus cisplatin

Interventions

gemcitabine plus cisplatinDRUG

gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion followed by cisplatin 70 mg/m2 on day 1 as an 2 hour infusion

Also known as: gemzar (gemcitabine) plus cisplatin (= cisplatin)
gemcitabine plus cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • bone marrow reserve (neutrophil count \>1500 cells per μL,platelet count \>100 000 per μL) count
  • hepatic function (serum bilirubin \<2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
  • renal function with a creatinine clearance \>60ml/min

You may not qualify if:

  • metastatic disease
  • serious or uncontrolled concurrent medical illness
  • pregnancy
  • history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
  • non-transitional cell bladder cancer
  • creatinine clearance \<60ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barmherzige Brüder Vienna

Vienna, Vienna, 1020, Austria

Location

Related Publications (2)

  • Dash A, Pettus JA 4th, Herr HW, Bochner BH, Dalbagni G, Donat SM, Russo P, Boyle MG, Milowsky MI, Bajorin DF. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer. 2008 Nov 1;113(9):2471-7. doi: 10.1002/cncr.23848.

    PMID: 18823036BACKGROUND

  • Tolerability of neoadjuvant chemotherapy with gemcitabine plus cisplatin in elderly (older than age 65) patients (pts) with muscle-invasive urothelial cancer. D. Niedersuess-Beke, B. Gruenberger, T. Puntus, W. Bauer, M. Lamche, P. Schramek, J. G. Meran; Barmherzige Brueder Hospital, Vienna, Austria; Goettlicher Heiland Hospital, Vienna, Austria ´ J Clin Oncol 29: 2011 (suppl 7; abstr 296)

    RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

GemcitabineCisplatin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Johannes Meran, M.D.

    Barmherzige Brüder Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.Johannes Meran

Study Record Dates

First Submitted

February 15, 2013

First Posted

March 1, 2013

Study Start

April 1, 2007

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

AU(1)