Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma (COACH)
This study is currently recruiting participants.
Verified December 2011 by Asan Medical Center
Sponsor:
Asan Medical Center
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
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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:
Drug Information available for:
Cisplatin
Carboplatin
Oxaliplatin
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
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 May 22, 2013