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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Korea Association for Clinical Oncology
Korean Urologic Oncology Society
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01487915
First received: December 5, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Advanced Urothelial Carcinoma
Drug: GCb
Drug: GemOx
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Response rate based on RECIST 1.1


Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety according to NCI CTCAE v.4.03

  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487915

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

Locations
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.         
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.         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Kyeong Hwa Park, 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
Korea Association for Clinical Oncology
Korean Urologic Oncology Society
  More Information

No publications provided

Responsible Party: JLee, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01487915     History of Changes
Other Study ID Numbers: UOSG-AMC-1001, KCSG-GU10-16
Study First Received: December 5, 2011
Last Updated: December 6, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Cisplatin-unfit condition

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Oxaliplatin
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014