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

Advanced Urothelial Carcinoma Clinical Trial

— COACH  

Official title:

Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01487915
• Other study ID #: UOSG-AMC-1001
• Secondary ID: KCSG-GU10-16
• Status: Recruiting
• Phase: Phase 2
• First received: December 5, 2011
• Last updated: September 22, 2014
• Start date: October 2010

Study information

• Verified date: September 2014
• Source: Asan Medical Center
• Contact: Jae-Lyun Lee, MD, PhD
• Phone: 82 2 3010 5977
• Email: jaelyun[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Urothelial Carcinoma
• Carcinoma
• Carcinoma, Transitional Cell

Intervention

Drug:
• GCb
Gemcitabine 1000 mg/? D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
• GemOx
Gemcitabine 1000 mg/? D1 plus Oxaliplatin 100 mg/? D1 every 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Keimyeong University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung Ang University Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Response rate based on RECIST 1.1	12 weeks	No
Secondary	Safety	Safety according to NCI CTCAE v.4.03	12 months	Yes
Secondary	Progression-free survival		1 year	No
Secondary	Overall survival		1 year	No