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Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC) (XP+Sorafenib)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00565370
Recruitment Status : Completed
First Posted : November 29, 2007
Results First Posted : August 31, 2015
Last Update Posted : August 21, 2017
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Brief Summary:
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: Capecitabine, Cisplatin, Sorafenib Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
Study Start Date : November 2007
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Drug: Capecitabine, Cisplatin, Sorafenib
Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks
Placebo Comparator: B
Drug: Capecitabine, Cisplatin, Sorafenib
Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks

Primary Outcome Measures :
  1. Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) [ Time Frame: 28weeks ]
    Number of Participants who Experienced Dose Limiting Toxicities (DLTs)

  2. Progression-free Survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 6 months ]

    Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate

  2. Overall Survival [ Time Frame: 28 months ]
  3. Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0) [ Time Frame: 28weeks ]
    Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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): NCT00565370

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Study Chair: Yoon-Koo Kang, MD, PhD Asan Medical Center

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00565370     History of Changes
Other Study ID Numbers: AMC-ONCGI-0701
First Posted: November 29, 2007    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: August 21, 2017
Last Verified: July 2017

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Gastric cancer
phase I
phase II

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs