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

Asan Medical Center

Status and phase: Unknown; Phase 2

Conditions: Advanced Urothelial Carcinoma

Treatments: Drug: GCb; Drug: GemOx

Study type: Interventional

Funder types: Other

Identifiers

NCT01487915

KCSG-GU10-16 (Other Identifier)

UOSG-AMC-1001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

GCb

Active Comparator group

Description:

Gemcitabine plus Carboplatin

Treatment:

Drug: GCb

GemOx

Experimental group

Description:

Gemcitabine plus Oxaliplatin

Treatment:

Drug: GemOx