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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Advanced Urothelial Carcinoma Drug: GCb Drug: GemOx Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
Study Start Date : October 2010
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 12 weeks ]
    Response rate based on RECIST 1.1


Secondary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]
    Safety according to NCI CTCAE v.4.03

  2. Progression-free survival [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487915


Contacts
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Contact: Jae-Lyun Lee, MD, PhD 82 2 3010 5977 jaelyun@amc.seoul.kr
Contact: Jeong-Mi Ko, MSc crnonc8@amc.seoul.kr

Locations
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Korea, Republic of
Keimyeong University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Hong Seok Song, MD, PhD.         
Contact: Jin Young Kim, MD         
Chungnam University Hospital Recruiting
Daejeon, Korea, Republic of, 301-721
Contact: Hyo Jin Lee, MD, PhD.         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Kyeong Hwa Park, MD, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jeong-Mi Ko, MSc       crnonc8@amc.seoul.kr   
Principal Investigator: Jae-Lyun Lee, MD, PhD.         
Sub-Investigator: Jin-Hee Ahn, MD, PhD.         
Sub-Investigator: Hanjong Ahn, MD, PhD.         
Sub-Investigator: Jun Hyuk Hong, MD, PhD.         
Sub-Investigator: Cheryn Song, MD, PhD.         
Sub-Investigator: Cheong Soo Kim, MD, PhD.         
Chung Ang University Hospital Not yet recruiting
Seoul, Korea, Republic of, 156-755
Contact: Hee Joon Kim, MD         
Sponsors and Collaborators
Asan Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: JLee, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01487915    
Other Study ID Numbers: UOSG-AMC-1001
KCSG-GU10-16 ( Other Identifier: Korean Cancer Study Group )
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by JLee, Asan Medical Center:
Cisplatin-unfit condition
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms