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

September 22, 2014 updated by: JLee, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Recruiting
        • Keimyeong University Dongsan Medical Center
        • Contact:
          • Hong Seok Song, MD, PhD.
        • Contact:
          • Jin Young Kim, MD
      • Daejeon, Korea, Republic of, 301-721
        • Recruiting
        • Chungnam University Hospital
        • Contact:
          • Hyo Jin Lee, MD, PhD.
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Jae-Lyun Lee, MD, PhD.
        • Sub-Investigator:
          • Jin-Hee Ahn, MD, PhD.
        • Sub-Investigator:
          • Jun Hyuk Hong, MD, PhD.
        • Sub-Investigator:
          • Cheong Soo Kim, MD, PhD.
      • Seoul, Korea, Republic of, 136-705
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Kyeong Hwa Park, MD, PhD
      • Seoul, Korea, Republic of, 156-755
        • Not yet recruiting
        • Chung Ang University Hospital
        • Contact:
          • Hee Joon Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GCb
Gemcitabine plus Carboplatin
Drug: GCb
Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
Experimental: GemOx
Gemcitabine plus Oxaliplatin
Drug: GemOx
Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 22, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOSG-AMC-1001
  • KCSG-GU10-16 (Other Identifier: Korean Cancer Study Group)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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