Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Disseminated Intravascular Coagulation; Bone Marrow Metastasis

Treatments: Drug: Docetaxel; Drug: 5-fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT04547153

ZhenLong

Details and patient eligibility

About

A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).

Full description

5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG PS 0-3;
• Pathologically confirmed adenocarcinoma in stomach or esophagogastric junction;
• Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan;
• overt DIC according to the International Society on Thrombosis and Haemostasis (ISTH) criteria;
• Treatment-naive after the diagnosis of metastasis;
• Platelet ≤ 50 * 10E9/L;
• ALT≤5×ULN, AST≤5×ULN, Bilirubin≤5×ULN, Creatinine≤3×ULN;
• Written informed consent.

Exclusion criteria

• Concurrent aggressive malignancy;
• Docetaxel containing perioperative treatment within 6 months;
• Allergic to the study drugs;
• Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc.
• HIV positive;
• MSI-H;
• Her-2 gene overexpression;
• Inadequate contraceptive measures.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

LD-FUD (Zhen Long)

Experimental group

Description:

5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.

Treatment:

Drug: Docetaxel

Drug: 5-fluorouracil