Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma

Phase 2

• Conditions: Advanced Urothelial Carcinoma
• Interventions: Drug: GCb; Drug: GemOx

• Registration Number: NCT01487915
• Lead Sponsor: Asan Medical Center

Brief Summary

Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.

But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.

Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.

But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens.

GemOx has been reported to be effective and have very favorable toxicity profiles.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-22
• Last Update Posted: 2014-09-25
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Cytologically of histologically confirmed urothelial carcinoma
• Locally advanced or metastatic disease
• Measurable disease according to RECIST v.1.1
• ECOG PS 0-2
• Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2)
• Adequate organ function
• Chemotherapy-naive

Exclusion Criteria

• Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed
• CNS metastases
• Peripheral neuropathy grade 2 or worse
• Serious medical or surgical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GCb	GCb	Gemcitabine plus Carboplatin
GemOx	GemOx	Gemcitabine plus Oxaliplatin

Primary Outcome Measures

Name	Time	Method
Response rate	12 weeks	Response rate based on RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Safety	12 months	Safety according to NCI CTCAE v.4.03
Progression-free survival	1 year
Overall survival	1 year

Trial Locations

Locations (5)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyeong University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chung Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of