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

Primary Purpose

Advanced Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Capecitabine, Cisplatin, Sorafenib
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Gastric cancer, capecitabine, cisplatin, sorafenib, phase I, phase II

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

XP+sorafenib

XP

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Progression-free Survival

Secondary Outcome Measures

Response Rate
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
Overall Survival
Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)
Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib

Full Information

First Posted
November 28, 2007
Last Updated
January 6, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00565370
Brief Title
Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP
Official Title
A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
Keywords
Gastric cancer, capecitabine, cisplatin, sorafenib, phase I, phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
XP+sorafenib
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
XP
Intervention Type
Drug
Intervention Name(s)
Capecitabine, Cisplatin, Sorafenib
Intervention Description
Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Description
Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Time Frame
28weeks
Title
Progression-free Survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Response Rate
Description
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
Time Frame
6 months
Title
Overall Survival
Time Frame
28 months
Title
Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)
Description
Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib
Time Frame
28weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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