Second-Line Irinotecan vs. ILF for AGC

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 2

Conditions: Stomach Neoplasm; Second-Line; Metastatic

Treatments: Drug: ILF; Drug: irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT00509964

GMO-GI-71

Details and patient eligibility

About

Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy. However, over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders, the duration of responses was as short as a few months. Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available.

We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed gastric cancer
• inoperable, recurrent, or metastatic
• performance status 0 to 2
• failed after one or more prior chemotherapy for advanced disease
• informed consent

Exclusion criteria

• active infection
• severe co-morbidities
• previously treated with irinotecan or similar drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.

Treatment:

Drug: irinotecan

2

Active Comparator group

Description:

Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and infusional 5-fluorouracil, on day 1 every 2 weeks.

Treatment:

Drug: ILF