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Phase II Trial of Gemcitabine, Cisplatin, Plus Ipilimumab as First-line Treatment for Patients With Metastatic Urothelial Carcinoma: Hoosier Oncology Group GU10-148

Phase 2
18 Years
Open (Enrolling)
Urothelial Carcinoma

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Trial Information

Phase II Trial of Gemcitabine, Cisplatin, Plus Ipilimumab as First-line Treatment for Patients With Metastatic Urothelial Carcinoma: Hoosier Oncology Group GU10-148

OUTLINE: This is a multi-center study

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

Treatment during the induction phase will be administered in six 21-day cycles. During
cycles 1 and 2, gemcitabine plus cisplatin will be administered WITHOUT ipilimumab. During
cycles 3-6, combination therapy with gemcitabine, cisplatin, plus ipilimumab will be
administered. Patients without evidence of disease progression (by irRC) after completion
cycle 6 will continue single-agent ipilimumab maintenance every 3 months.

Karnofsky performance status (KPS) ≥ 80% within 14 days prior to registration for protocol

Life Expectancy: Not Specified


- White blood cell count (WBC) ≥ 3.5K/mm3

- Hemoglobin (Hgb) ≥ 9 g/dL

- Platelets ≥ 100K/mm3

- Absolute neutrophil count (ANC) ≥ 1.5k/mm3


- Bilirubin ≤ 1.5 times x Upper Limit of Normal (ULN) (except patients with Gilbert's
Syndrome, who must have a total bilirubin less than 3.0 mg/dL)

- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN. NOTE: If the patient has liver
metastases present, then ≤ 5 x ULN


- Calculated creatinine clearance of ≥ 55 cc/min using the Cockcroft-Gault formula

Cardiovascular: Not Specified

Inclusion Criteria:

- Histological or cytological proof of urothelial carcinoma of the urethra, bladder,
ureters, or renal pelvis.

- Advanced (clinical stage T4b, unresectable) or metastatic disease.

- Prior radiation therapy is allowed to < 25% of the bone marrow.

- Age > 18 years at the time of consent.

- Written informed consent and HIPAA authorization for release of personal health

- Females must not be pregnant or breastfeeding.

- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L
or equivalent units of HCG) within 72 hours before the start of ipilimumab.

- Men of fathering potential must be using an adequate method of contraception to avoid
conception throughout the study [and for up to 26 weeks after the last dose of
investigational product] in such a manner that the risk of pregnancy is minimized.

- Prior Autoimmune disease: Patients with a history of inflammatory bowel disease,
including ulcerative colitis and Crohn's Disease, are excluded from this study, as
are patients with a history of symptomatic disease (eg, rheumatoid arthritis,
systemic progressive sclerosis [scleroderma], systemic lupus erythematosus,
autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of
autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with
other immune disorders should not be enrolled without discussion with the principal

Exclusion Criteria:

- No active CNS metastases. Subjects with neurological symptoms must undergo a head CT
scan or brain MRI to exclude brain metastasis.

- No prior malignancy is allowed except for cancers that have been definitively treated
with a risk of recurrence of < 30% based on the treating oncologists assessment.

- Patients may not have received prior systemic chemotherapy for metastatic/advanced
urothelial carcinoma. Prior neoadjuvant/adjuvant therapy is permitted if completed ≥
12 months prior to registration for protocol therapy. Prior intravesical therapy is

- No treatment with any investigational agent within 30 days prior to registration for
protocol therapy.

- No underlying medical or psychiatric condition, which in the opinion of the
investigator will make the administration of ipilimumab hazardous or obscure the
interpretation of AEs, such as a condition associated with frequent diarrhea.

- No non-oncology vaccine therapy used for prevention of infectious diseases (for up to
1 month before or after any dose of ipilimumab).

- No history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4
inhibitor or agonist.

- No known active or chronic infection with HIV, Hepatitis B, or Hepatitis C.

- No clinically significant infections as judged by the treating investigator.

- No chronic systemic corticosteroids (defined as the equivalent of prednisone ≥ 20 mg
PO daily for > 6 months during the past year)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

One-Year Overall Survival

Outcome Description:

To determine the 1-year overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Matthew Galsky, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

June 2014

Related Keywords:

  • Urothelial Carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell



Virginia Oncology Associates Newport News, Virginia  23606
Methodist Cancer Center Omaha, Nebraska  68114
Texas Oncology, PA Dallas, Texas  75246-2006
Indiana University Melvin & Bren Simon Cancer Center Indianapolis, Indiana  46202
IU Health Central Indiana Cancer Centers Indianapolis, Indiana  46219
Tisch Cancer Institute at Mount Sinai Medical Center New York, New York  10029
IU Health Goshen Hospital Goshen, Indiana  46527