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

NCT00565370 | Completed Phase 1 Results

• 1 other identifier: AMC0701
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Keywords

Gastric cancer; capecitabine; cisplatin; sorafenib; phase I; phase II

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)

  Number of Participants who Experienced Dose Limiting Toxicities (DLTs)

  28weeks

• Progression-free Survival

  1 year

Secondary Outcomes (3)

• Response Rate

  6 months

• Overall Survival

  28 months

• Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)

  28weeks

Study Arms (2)

A

EXPERIMENTAL

XP+sorafenib

Drug: Capecitabine, Cisplatin, Sorafenib

B

PLACEBO COMPARATOR

XP

Drug: Capecitabine, Cisplatin, Sorafenib

Interventions

Capecitabine, Cisplatin, Sorafenib DRUG

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

A; B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[5 times for patients with liver metastasis\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Cisplatin; Sorafenib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: Dr. Yoon-Koo Kang
• Organization: Asan Medical Center

ykkang@amc.seoul.kr

+82-2-3010-3210

Study Officials

• Yoon-Koo Kang, MD, PhD

  Asan Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 29, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 18, 2020
• Results First Posted: August 31, 2015

Record last verified: 2020-01

Locations

KR (1)