Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 2

Conditions: Stage IV; Stomach Neoplasm; Recurrent

Treatments: Drug: Cisplatin; Drug: oxaliplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00510107

GMO-GI-72

Details and patient eligibility

About

To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.

Full description

Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main causes of cancer death. While treatment options for AGC have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity profile suggests a potential for better tolerance and increased dose intensity.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically proven gastric cancer
• aged 75 years or less
• performance status 0 to 2
• no prior chemotherapy
• inoperable, recurrent, or metastatic
• normal marrow, hepatic and renal functions

Exclusion criteria

• active infections
• severe co-morbidities
• pregnant or lactating women
• active brain metastasis
• neuropathy of grade 2 or higher

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

1

Active Comparator group

Description:

Docetaxel 35 mg/m2 will be administered on days 1 and 8. Cisplatin 60 mg/m2 will be administered on day 1 every 3 weeks.

Treatment:

Drug: Cisplatin

2

Experimental group

Description:

Docetaxel 35 mg/m2 will be administered on days 1 and 8. Oxaliplatin 120 mg/m2 will be administered on day 1 every 3 weeks.

Treatment:

Drug: oxaliplatin