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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT00565370 |
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Date of registration:
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28/11/2007 |
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Primary sponsor: |
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Public title:
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Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC)
XP+Sorafenib |
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Scientific title:
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A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00565370 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Yoon-Koo Kang, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Having given signed written informed consent
- Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
- No history of chemotherapy or radiation
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Age 18-75 years
- Estimated life expectancy of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets >
100,000/µL, hemoglobin > 8g/dl),
- Adequate kidney function (creatinine clearance > 60 ml/min)
- Adequate liver function (bilirubin < 2.0 mg/dL, transaminases levels < 3 times the
upper normal limit [5 times for patients with liver metastasis])
Exclusion Criteria:
- Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for
curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start
- Presence of central nervous system metastasis
- Obvious peritoneal seeding or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy (National Cancer Institute Common Terminology Criteria for
Adverse Event version 3.0 > Grade I)
- History of significant neurologic or psychiatric disorders
- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception
- Other serious illness or medical conditions
- Known allergy to study drugs
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Gastric Cancer
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Intervention(s)
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Drug: Capecitabine, Cisplatin, Sorafenib
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Primary Outcome(s)
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Maximum tolerated dose for phase I portion
[Time Frame: 3 weeks]
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Progression-free survival for phase II portion
[Time Frame: 1 year]
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Secondary Outcome(s)
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Overall survival
[Time Frame: 1 year]
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Response rate
[Time Frame: 6 months]
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Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event version 3.0)
[Time Frame: Each cycle of chemotherapy]
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Secondary ID(s)
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AMC-ONCGI-0701
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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