NCT01487915

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

4.7 years

First QC Date

December 5, 2011

Last Update Submit

September 22, 2014

Conditions

Advanced Urothelial Carcinoma

Keywords

Cisplatin-unfit condition

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Response rate based on RECIST 1.1

    12 weeks

Secondary Outcomes (3)

  • Safety

    12 months

  • Progression-free survival

    1 year

  • Overall survival

    1 year

Study Arms (2)

GCb

ACTIVE COMPARATOR

Gemcitabine plus Carboplatin

Drug: GCb

GemOx

EXPERIMENTAL

Gemcitabine plus Oxaliplatin

Drug: GemOx

Interventions

GCbDRUG

Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks

GCb
GemOxDRUG

Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks

GemOx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Keimyeong University Dongsan Medical Center

Daegu, 700-712, South Korea

RECRUITING

Chungnam University Hospital

Daejeon, 301-721, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 136-705, South Korea

RECRUITING

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Chung Ang University Hospital

Seoul, 156-755, South Korea

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 31668839DERIVED

Central Study Contacts

Jae-Lyun Lee, MD, PhD

CONTACT

82 2 3010 5977jaelyun@amc.seoul.kr

Jeong-Mi Ko, MSc

CONTACT

crnonc8@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 8, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2015

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

KR(5)