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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00565370
First received: November 28, 2007
Last updated: January 16, 2013
Last verified: January 2013

November 28, 2007
January 16, 2013
November 2007
December 2009   (final data collection date for primary outcome measure)
  • Maximum tolerated dose for phase I portion [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Progression-free survival for phase II portion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00565370 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event version 3.0) [ Time Frame: Each cycle of chemotherapy ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC)
A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Gastric Cancer
Drug: Capecitabine, Cisplatin, Sorafenib
Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks
Experimental: A
XP+sorafenib
Intervention: Drug: Capecitabine, Cisplatin, Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00565370
AMC-ONCGI-0701
No
Yoon-Koo Kang, Asan Medical Center
Asan Medical Center
Not Provided
Study Chair: Yoon-Koo Kang, MD, PhD Asan Medical Center
Asan Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP