Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer (XPID)
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ClinicalTrials.gov Identifier: NCT01525771 |
Recruitment Status :
Completed
First Posted : February 3, 2012
Last Update Posted : June 29, 2015
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Condition or disease | Intervention/treatment | Phase |
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Stage IV Gastric Cancer With Metastasis | Other: Docetaxel | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
No Intervention: No intervention
Single-center, open-label, prospective, single-arm, phase I-II study
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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.
Other Names:
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- 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
- Safety profile [ Time Frame: 1 year ]
- Overall survival [ Time Frame: 1 year ]
- Progression free survival [ Time Frame: 1 year ]
- efficacy [ Time Frame: 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
- Peritoneal seeding proven by histology or cytology
- 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)
- Age 18 to 70 years old
- Eastern Cooperative Oncology Group performance status <_ 2
- Estimated life expectancy of more than 3 months
- Adequate bone marrow function (WBCs>3,000/µL and absolute neutrophil count (ANC) >1,500/µL and platelets>100,000/µL),
- Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance _> 60ml/min
- 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)
- Written informed consent
Exclusion Criteria:
- Contraindication to any drug contained in the chemotherapy regimen
- Other tumor type than adenocarcinoma
- Presence or history of CNS metastasis
- Gastric outlet or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy > grade 2
- History of significant neurologic or psychiatric disorders
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525771
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of |
Principal Investigator: | Min-Hee Ryu, MD | Asan Medical Center/Univ of Ulsan |
Responsible Party: | Min-Hee Ryu, Associate Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01525771 |
Other Study ID Numbers: |
AMC-XPID-1 |
First Posted: | February 3, 2012 Key Record Dates |
Last Update Posted: | June 29, 2015 |
Last Verified: | June 2015 |
Advanced Gastric cancer Xeloda (Capecitabine) Cisplatin Taxotere (Docetaxel) |
Stomach Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Cisplatin |
Docetaxel Capecitabine Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |