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OpenTrials
Completed

NCT Number: NCT00565370

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

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.

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Key information

Conditions

Advanced Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine, Cisplatin, Sorafenib

Drug

Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 29, 2007
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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