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

NCT04547153 | Completed Phase 2 DMC

• 1 other identifier: ZhenLong
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gastric Cancer; Bone Marrow Metastasis; Disseminated Intravascular Coagulation

Keywords

5-fluorouracil; docetaxel

Outcome Measures

Primary Outcomes (1)

• hematological response rate (HeRR)

  percentage of participants whose platelet restored to normal range

  2 months

Secondary Outcomes (5)

• time to hematological response (TTHeR)

  2 months

• one-month mortality (OMM)

  30 days

• overall survival (OS)

  2 years

• toxicities

  2 months

• quality of life assessed by EORTC QOL C-30 and STO-22 (QoL)

  3 months

Study Arms (1)

LD-FUD (Zhen Long)

EXPERIMENTAL

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.

Drug: 5-fluorouracil; Drug: Docetaxel

Interventions

5-fluorouracil DRUG

200mg/square metre/day civ D1-D21

Also known as: 5-Fu

LD-FUD (Zhen Long)

Docetaxel DRUG

25mg/square metre ivdrip D1, D8, D15

Also known as: D

LD-FUD (Zhen Long)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Jian Xiao

Guangzhou, Guangdong, 510655, China

Location

Related Publications (3)

• Morita R, Ishikawa T, Sawai Y, Kajiwara M, Asaeda K, Kobayashi R, Miyazaki H, Doi T, Inoue K, Dohi O, Yoshida N, Kamada K, Uchiyama K, Takagi T, Konishi H, Naito Y, Itoh Y. [A Long-Term Survival Case of Gastric Cancer with Disseminated Intravascular Coagulation due to Myelocarcinomatosis Treated with S-1 plus Oxaliplatin Therapy]. Gan To Kagaku Ryoho. 2021 May;48(5):731-734. Japanese.

  PMID: 34006725 BACKGROUND

• Kwon JY, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Kim HJ, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Hong DS, Park HS. Clinical outcome of gastric cancer patients with bone marrow metastases. Cancer Res Treat. 2011 Dec;43(4):244-9. doi: 10.4143/crt.2011.43.4.244. Epub 2011 Dec 27.

  PMID: 22247710 BACKGROUND

• Xiaohui Z, Shanshan L, Taiyuan C, Ge D, Hongen Y, Lishuo S, Xiaoru L, Wanjia H, Jian X. Docetaxel and fluorouracil as first-line therapy for gastric cancer with bone marrow metastasis and disseminated intravascular coagulation. Future Oncol. 2022 Nov;18(35):3875-3880. doi: 10.2217/fon-2022-0748. Epub 2022 Nov 8.

  PMID: 36346044 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Disseminated Intravascular Coagulation

Interventions

Fluorouracil; Docetaxel; Fumigant 93

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jian Xiao, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: January 15, 2021
• Primary Completion: February 25, 2024
• Study Completion: March 22, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: July 2024 - June 2027
• Access Criteria: Researchers interested in the same disease

Locations

CN (1)