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Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma (COACH)

Primary Purpose

Advanced Urothelial Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GCb
GemOx
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Urothelial Carcinoma focused on measuring Cisplatin-unfit condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyeong University Dongsan Medical CenterRecruiting
  • Chungnam University HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Chung Ang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GCb

GemOx

Arm Description

Gemcitabine plus Carboplatin

Gemcitabine plus Oxaliplatin

Outcomes

Primary Outcome Measures

Response rate
Response rate based on RECIST 1.1

Secondary Outcome Measures

Safety
Safety according to NCI CTCAE v.4.03
Progression-free survival
Overall survival

Full Information

First Posted
December 5, 2011
Last Updated
September 22, 2014
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01487915
Brief Title
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
Acronym
COACH
Official Title
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Urothelial Carcinoma
Keywords
Cisplatin-unfit condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GCb
Arm Type
Active Comparator
Arm Description
Gemcitabine plus Carboplatin
Arm Title
GemOx
Arm Type
Experimental
Arm Description
Gemcitabine plus Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
GCb
Intervention Description
Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
GemOx
Intervention Description
Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
Primary Outcome Measure Information:
Title
Response rate
Description
Response rate based on RECIST 1.1
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety
Description
Safety according to NCI CTCAE v.4.03
Time Frame
12 months
Title
Progression-free survival
Time Frame
1 year
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Lyun Lee, MD, PhD
Phone
82 2 3010 5977
Email
jaelyun@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Mi Ko, MSc
Email
crnonc8@amc.seoul.kr
Facility Information:
Facility Name
Keimyeong University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Seok Song, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Jin Young Kim, MD
Facility Name
Chungnam University Hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo Jin Lee, MD, PhD.
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyeong Hwa Park, MD, PhD
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Mi Ko, MSc
Email
crnonc8@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Jae-Lyun Lee, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Jin-Hee Ahn, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Hanjong Ahn, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Jun Hyuk Hong, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Cheryn Song, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Cheong Soo Kim, MD, PhD.
Facility Name
Chung Ang University Hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Joon Kim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31668839
Citation
Park I, Kim BS, Lim HY, Kim HJ, Lee HJ, Choi YJ, Park KH, Lee KH, Yoon S, Hong B, Hong JH, Ahn H, Lee JL. Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16). Eur J Cancer. 2020 Mar;127:183-190. doi: 10.1016/j.ejca.2019.08.034. Epub 2019 Oct 24.
Results Reference
derived

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

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