Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 10:14 PM
Study NCT ID:
NCT01487915
Status:
None
Last Update Posted:
2014-09-25 00:00:00
First Post:
2011-12-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
Sponsor:
None
Organization:
Study Overview
Official Title:
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study
Status:
None
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COACH
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: