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

• ClinicalTrials.gov Identifier: NCT01525771
• Recruitment Status: Completed
• First Posted: February 3, 2012
• Last Update Posted: June 29, 2015
• Sponsor: Asan Medical Center
• Information provided by (Responsible Party): Min-Hee Ryu, Asan Medical Center

Tracking Information

• First Submitted Date: July 18, 2011
• First Posted Date: February 3, 2012
• Last Update Posted Date: June 29, 2015
• Study Start Date: February 2011
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2013)

Maximum tolerated dose [ Time Frame: 1 year ]

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

Original Primary Outcome Measures (submitted: February 1, 2012)

R0 resection rate [ Time Frame: 1 year ]

to assess the R0 resection rate with the study medication.

Current Secondary Outcome Measures (submitted: April 22, 2013)

• Safety profile [ Time Frame: 1 year ]
• Overall survival [ Time Frame: 1 year ]
• Progression free survival [ Time Frame: 1 year ]
• efficacy [ Time Frame: 1 year ]

Original Secondary Outcome Measures (submitted: February 1, 2012)

• Safety profile [ Time Frame: 1 year ]
• Overall survival [ Time Frame: 1 year ]
• Progression free survival [ Time Frame: 1 year ]
• Pathologic Complete Response rate [ Time Frame: 1 year ]
• Angiogenetic biomarkers [ Time Frame: 1 year ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer
• Official Title: A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding
• Brief 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)

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stage IV Gastric Cancer With Metastasis

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

Other Names:

• XP with Intraperitoneal Docetaxel
• Capecitabine
• Cisplatin

Study Arms

No Intervention: No intervention

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

Intervention: Other: Docetaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2012): 37
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01525771
• Other Study ID Numbers: AMC-XPID-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Min-Hee Ryu, Asan Medical Center
• Study Sponsor: Asan Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Min-Hee Ryu, MD; Asan Medical Center/Univ of Ulsan

• PRS Account: Asan Medical Center
• Verification Date: June 2015