Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in... | NCT01487915

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

NCT01487915

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

Sep 25, 2014Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Advanced Urothelial Carcinoma

Interventions

GCb
GemOx

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KCSG-GU10-16	Other Identifier	Korean Cancer Study Group

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 5, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GCb	Active Comparator	Gemcitabine plus Carboplatin	Drug: GCb
GemOx	Experimental	Gemcitabine plus Oxaliplatin	Drug: GemOx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GCb	Drug	Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks	GCb

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate	Response rate based on RECIST 1.1	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety	Safety according to NCI CTCAE v.4.03	12 months
Progression-free survival		1 year
Overall survival

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jae-Lyun Lee, MD, PhD	Contact	82 2 3010 5977		jaelyun@amc.seoul.kr
Jeong-Mi Ko, MSc	Contact			crnonc8@amc.seoul.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keimyeong University Dongsan Medical Center	Recruiting	Daegu		700-712	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31668839	Derived	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.