NCT01525771

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Stage IV Gastric Cancer With Metastasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-02-03
• Last updated: 2015-06-29

Locations

1 site across 1 country: South Korea