Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer

Stage IV Gastric Cancer With Metastasis Clinical Trial

— XPID  

Official title:

A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525771
• Other study ID #: AMC-XPID-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 18, 2011
• Last updated: June 26, 2015
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.

Description:

Single-center, open-label, prospective, single-arm, phase I-II study

About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology

2. Peritoneal seeding proven by histology or cytology

3. Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded)

4. Age 18 to 70 years old

5. Eastern Cooperative Oncology Group performance status <_ 2

6. Estimated life expectancy of more than 3 months

7. Adequate bone marrow function (WBCs>3,000/µL and absolute neutrophil count (ANC) >1,500/µL and platelets>100,000/µL),

8. Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance _> 60ml/min

9. Adequate hepatic function: bilirubin < 1.5 x UNL, AST/ALT levels < 2.5 x UNL, alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)

10. Written informed consent

Exclusion Criteria:

1. Contraindication to any drug contained in the chemotherapy regimen

2. Other tumor type than adenocarcinoma

3. Presence or history of CNS metastasis

4. Gastric outlet or bowel obstruction

5. Evidence of serious gastrointestinal bleeding

6. Peripheral neuropathy > grade 2

7. History of significant neurologic or psychiatric disorders

8. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix

9. Pregnant or lactating women, women of childbearing potential not employing adequate contraception

10. Other serious illness or medical conditions

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stage IV Gastric Cancer With Metastasis
• Stomach Neoplasms

Intervention

Other:
• Docetaxel
The study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients. Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100) Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days Cisplatin 60mg/m2 IV (D1) every 21 days

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose	Phase I Study; - Maximum tolerated dose of Intraperitoneal Docetaxel; Phase II Study; Progression-free survival rate at 6 months; response rate, time to progression, overall survival	1 year	No
Secondary	Safety profile		1 year	No
Secondary	Overall survival		1 year	No
Secondary	Progression free survival		1 year	No
Secondary	efficacy		1 year	No