NCT01524991

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 therapy. Life Expectancy: Not Specified Hematopoietic: * White blood cell count (WBC) ≥ 3.5K/mm3 * Hemoglobin (Hgb) ≥ 9 g/dL * Platelets ≥ 100K/mm3 * Absolute neutrophil count (ANC) ≥ 1.5k/mm3 Hepatic: * 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 Renal: * Calculated creatinine clearance of ≥ 55 cc/min using the Cockcroft-Gault formula Cardiovascular: Not Specified

Conditions

• Urothelial Carcinoma

Interventions

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

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-07-15
• Completion: 2018-12-31
• First posted: 2012-02-02
• Last updated: 2022-07-11
• Results posted: 2019-11-29

Locations

8 sites across 1 country: United States