Phase II Study of Neoadjuvant XELOX + Lapatinib in HER2(+) Gastric Cancer Patients With Liver Metastasis

NCT02015169 | Completed Phase 2 DMC

• 1 other identifier: 2012-05-078
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

We planned this study to investigate the efficacy and safety of XELOX (capecitabine and oxaliplatin) plus lapatinib treatment in HER2-positive gastric cancer patients with liver metastasis.

Conditions

HER2-positive Gastric Cancer Patients With Liver Metastasis

Keywords

gastric cancer; neoadjuvant chemotherapy; capecitabine; oxaliplatin; lapatinib

Outcome Measures

Primary Outcomes (1)

• complete resection rate (R0 resection rate) (defined as no macroscopic or microscopic residual tumor).

  after surgery, up to 3weeks

Secondary Outcomes (5)

• response rate based on RECIST 1.1

  every 3 cycles, up to 24weeks

• disease-free survival

  after surgery, every 3 months

• progression-free survival

  every 3 cycles for 6 months and ten every 3 months up to 3 years

• safety and toxicity based on NCI CTCAE ver. 4.0

  every cycles, up to 24 weeks

• Exploratory biomarker analysis

  every 3 cycles, up to 24weeks

Study Arms (1)

XELOX+lapatinib

EXPERIMENTAL

D1 Oxaliplatin130mg/m2 + D5W 500ml MIV over 2hrs D1-D14 Capecitabine 850mg/m2 p.o bid D1 \~ Lapatinib 1250 mg qd dailiy

Drug: Lapatinib

Interventions

Lapatinib DRUG

lapatinib 1250mg qd daily up to 8 cycles (3 weeks \* 8 cycles = 24 weeks)

Also known as: Tykerb, GSK

XELOX+lapatinib

Eligibility Criteria

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

You may qualify if:

• Histologically proven gastric cancer with metastatic lesion(s) that is (are) unresectable
• locally advanced gastric cancer that are NOT resectable
• distant metastases limited to abdominal lymph node, liver only :Patients with liver metastasis : Number of liver metastasis between 2 and 5 or maximal diameter should be under 5 cm (2 = liver mets = 5 or maximal diameter = 5cm) No LN metastasis within group 3 and no bulky N2 metastasis Clinically no distant metastasis (lung metastasis, mediastinal LN metastasis, neck LN metastasis, bone metastasis, brain metastasis, and peritoneal seeding in abdominal and pelvis CT; in cases of suspicious peritoneal seeding in imaging without any evidence of ascites and/or peritoneal enhancement will be allowed to enter the study based on investigators' decision)
• chemo-naïve (adjuvant treatment will be allowed if the last date of treatment is ≥ 6 months from the study entry date
• Age ≥ 18
• ECOG performance 0 - 1
• Adequate organ function (AST and ALT ≤2x upper limit of normal, bilirubin ≤1.5 x upper limit of normal, and creatinine \< 1.5x upper limit of normal, platelet \> 100,000/ul, absolute neutrophil count ≥ 1,500/ul)
• At least one measurable lesion by RECIST 1.1 criteria
• HER 2 (+) by HercepTest(IHC 3+ alone, or IHC 2+ with FISH amplification)
• Written informed consent

You may not qualify if:

• Prior therapy for metastatic disease
• Pregnant or lactating women
• Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months
• Any comorbidities which are not suitable for general anesthesia and surgical resection
• Known immediate or delayed hypersensitivity reaction to lapatinib ,capecitabine, oxaliplatin or any other platinum compounds, any recipients.
• \) Subjects with DPD deficiency 9) Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) 10) Pre-existing hand and foot syndrome and peripheral neuropathy of grade 2 or greater 11) Subjects unsuitable to resection or general anesthesia

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Korea, 135-720, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Lapatinib; halofantrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeeyun Lee, MD, PhD

  Division of Oncology, Department of Medicine, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: December 19, 2013
• Study Start: July 9, 2012
• Primary Completion: July 17, 2017
• Study Completion: November 17, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

KR (1)