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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01487915
Recruitment Status : Unknown
Verified September 2014 by JLee, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : December 8, 2011
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE December 5, 2011
First Posted Date  ICMJE December 8, 2011
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2011)		 Response rate [ Time Frame: 12 weeks ]
Response rate based on RECIST 1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
  • Safety [ Time Frame: 12 months ]
    Safety according to NCI CTCAE v.4.03
  • Progression-free survival [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
Official Title  ICMJE Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Urothelial Carcinoma
Intervention  ICMJE
  • Drug: GCb
    Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
  • Drug: GemOx
    Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
Study Arms  ICMJE
  • Active Comparator: GCb
    Gemcitabine plus Carboplatin
    Intervention: Drug: GCb
  • Experimental: GemOx
    Gemcitabine plus Oxaliplatin
    Intervention: Drug: GemOx
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 6, 2011)		 80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01487915
Other Study ID Numbers  ICMJE UOSG-AMC-1001
KCSG-GU10-16 ( Other Identifier: Korean Cancer Study Group )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party JLee, Asan Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Asan Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asan Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP