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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: GCb
Gemcitabine plus Carboplatin
Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
Gemcitabine plus Oxaliplatin
Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
- Response rate [ Time Frame: 12 weeks ]Response rate based on RECIST 1.1
- 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 ]
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
|Contact: Jae-Lyun Lee, MD, PhD||82 2 3010 firstname.lastname@example.org|
|Contact: Jeong-Mi Ko, MScemail@example.com|
|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 firstname.lastname@example.org|
|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|