Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer
NCT ID: NCT01525771
Last Updated: 2015-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
37 participants
INTERVENTIONAL
2011-02-28
2014-12-31
Brief Summary
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Detailed Description
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About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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No intervention
Single-center, open-label, prospective, single-arm, phase I-II study
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Min-Hee Ryu
Associate Professor
Principal Investigators
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Min-Hee Ryu, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center/Univ of Ulsan
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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AMC-XPID-1
Identifier Type: -
Identifier Source: org_study_id
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