First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

Part of paid clinical trials in Duarte, California.

Sponsor
Hoosier Cancer Research Network
Study ID
NCT01524991
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
  • Cisplatin — DRUG
    Cisplatin 70 mg/m2 Day 1 (all cycles)
  • Ipilimumab — DRUG
    Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Study Details

Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab has shown intriguing activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more durable responses and improved outcomes.

Key Dates

Start date
Jan 31, 2012
Status verified
Jul 2022
Primary completion
Jul 15, 2017
Completion
Dec 31, 2018

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Primary Outcome Measure

Median Overall Survival [ Time Frame: 48 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope: DuarteDuarteCalifornia91010-
IU Health Goshen HospitalGoshenIndiana46527-
Indiana University Melvin & Bren Simon Cancer CenterIndianapolisIndiana46202-
IU Health Central Indiana Cancer CentersIndianapolisIndiana46219-
Nebraska Cancer SpecialistsOmahaNebraska68114-
Tisch Cancer Institute at Mount Sinai Medical CenterNew YorkNew York10029-
Texas Oncology, PADallasTexas75246-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Duarte, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
City of Hope: Duarte· Duarte, CAIU Health Goshen Hospital· Goshen, INIndiana University Melvin & Bren Simon Cancer Center· Indianapolis, INIU Health Central Indiana Cancer Centers· Indianapolis, INNebraska Cancer Specialists· Omaha, NETisch Cancer Institute at Mount Sinai Medical Center· New York, NY

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