The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites

Stomach Neoplasms Clinical Trial

Official title:

The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites Due to Far Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02779608
• Other study ID #: Ifen
• Status: Recruiting
• Phase: Phase 2
• First received: May 15, 2016
• Last updated: January 23, 2017
• Start date: January 20, 2017
• Est. completion date: June 2018

Study information

• Verified date: January 2017
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical Study to evaluate the effect, survival benefit and safety of intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant ascites.

Description:

Peritoneal metastasis(PM) is common in advanced gastric cancer and associated with a poor prognosis. The median survival time is 3 to 4 months and even shorter in the patients with malignant ascites. Systemic chemotherapy is considered to be less effective against peritoneal metastasis (PM) due to the existence of the blood-peritoneal barrier (BPB), which inhibits the movement of drugs from systemic circulation to the peritoneal cavity.

S-1 is one kind of oral fluoropyrimidine derivatives and has been reported to be effective on PM. Docetaxel (DTX) has a pharmacokinetic advantage after intraperitoneal（IP）delivery which is hundreds of times higher than systemic administration. The use of S-1 and docetaxel has been studied in some phase II trials. Fujiwara and Fushida reported the usefulness of IP docetaxel combined with oral S-1 regimen in gastric cancer with PM respectively，the median survival time can exceed 16 months and one year survival rate was over 70%. Therefore, the investigators suppose IP docetaxel and oral S-1 can also be effective for gastric cancer with malignant ascites and start this study.

This is a single center, open-label, prospective clinical trial. Patients with histological proven gastric cancer with ascites, who fulfill the inclusion and exclusion criteria, can be recruited in this study. Patients will be firstly received laparoscopic exploration for Peritoneal Cancer Index (PCI）score, extraction of 100ml ascites for cytology examination, and one peritoneal access port is implanted in the subcutaneous space of the lower abdomen. Then patients were treated with chemotherapy on the first day after operation, the regimen as follows: DTX is administered IP at a dose of 60 mg/m2 on day 1. DTX is diluted in 1 litre normal saline and administered through the implanted peritoneal access port over 1 hour. S-1 was administered orally twice daily at a dose of 80 mg/m2 per day for 14 consecutive days, followed by 7 days of rest. The treatment course will be repeated every three weeks until observation of disease progression or unacceptable toxicity. Before each intraperitoneal chemotherapy, investigators extract 50-100 ml ascites for cytology pathologic examination, the abdominal CT will be reviewed after every three course to evaluate the volume of ascites.

The volume of ascites before and after therapy, PCI scores, ascites cytology results, complications, side effects and conditions of survival state and follow-up will be recorded and analyzed to evaluate the effect, survival benefit and safety of this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 20-75years

2. Histologic confirmation of gastric adenocarcinoma

3. Positive peritoneal cytology or histological proven PM

4. Ascites in CT scan

5. Performance status (PS) = 2 on Eastern Cooperative Oncology Group (ECOG) scale

6. Adequate bone marrow and organ functions as defined below:

Leucocyte=3,000/ul Absolute neutrophil counts =1,500/uL Platelet=100,000/uL Total bilirubin=1.5mg/dl ALT,AST= 2x ULN serum creatinine =1.5mg/dl

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

8. Provision of written informed consent

Exclusion Criteria:

1. Presence of non-curable factors such as distant metastasis to liver or lung except of peritoneum

2. Other severe medical conditions such as symptomatic infectious disease,active hemorrhage/bleeding, or obstructive bowel disease

3. Life expectation = 3 months

4. With other malignant tumor

5. allergy to therapeutic drugs

Related Conditions & MeSH terms

• Ascites
• Peritoneal Metastasis
• Stomach Neoplasms

Intervention

Drug:
• intraperitoneal docetaxel
One peritoneal access port will be implanted in subcutaneous space of patients' abdominal wall after laparoscopic exploration.Then intraperitoneal docetaxel in 1litre normal saline will be administered through the port
• oral S-1
40mg/m² twice daily on day 1-14 every 3 weeks

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate of ascites	From date of enrollment to three cycles of treatment,the ascites is evaluated by the Japanese conventional five-point method	9 weeks
Secondary	one year survival rate	From date of enrollment until 1 year	1 year
Secondary	side effects of chemotherapy	Grade refers to Common Terminology Criteria for Adverse Events(CTCAE)Version4.0	1 week to 18 weeks