A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer

NCT01967875 | Terminated Phase 2

• 1 other identifier: CLOG1301
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine whether ERCC1(excision repair cross-complementation 1 ) expression has effects on platinum-based chemotherapy for patients with locally advanced or metastatic gastric cancer, and to explore if ERCC1 can act as a biological predictor for the individual therapy of gastric cancer

Conditions

Stomach Neoplasms

Keywords

Gastric Cancer; ERCC1; Platinum; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  2 years

Secondary Outcomes (6)

• Overall Survival(OS)

  2 years

• Objective Response Rate(ORR),Including Complete Response(CR) and Partial Response(PR)

  2 years

• Disease Control Rate(DCR), Including Complete Response(CR) , Partial Response(PR) and Stable Disease(SD)

  2 years

• Duration of Response

  2 years

• Safety(number and degree of adverse events)

  2 years

Study Arms (3)

H-A: ERCC1 High Expression Group A

ACTIVE COMPARATOR

XP：Capecitabine+Cisplatin

Drug: Capecitabine+Cisplatin

H-B: ERCC1 High Expression Group B

EXPERIMENTAL

DX：Docetaxel+Capecitabine

Drug: Docetaxel+Capecitabine

L: ERCC1 Low Expression Group

ACTIVE COMPARATOR

XP：Capecitabine+Cisplatin

Drug: Capecitabine+Cisplatin

Interventions

Capecitabine+Cisplatin DRUG

Cisplatin 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles.Capecitabine is to be continued until disease progression or intolerable toxicity.

Also known as: Xeloda

H-A: ERCC1 High Expression Group A; L: ERCC1 Low Expression Group

Docetaxel+Capecitabine DRUG

Docetaxel 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles. Capecitabine is to be continued until disease progression or intolerable toxicity.

Also known as: Docetaxel for injection, Xeloda

H-B: ERCC1 High Expression Group B

Eligibility Criteria

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

You may qualify if:

• y≤Age≤65y, male or female
• KPS≥70
• Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease
• At least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), assessed using imaging techniques (CT or MRI)
• No prior anti-tumor treatment or an interval of at least 6 months from the last adjuvant chemotherapy, and an interval of at least 4 weeks from the last radical radiation therapy
• No major organ disorder, with normal liver, kidney and heart function
• Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
• Life expectancy of at least 12 weeks
• Signed informed consent
• For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment

You may not qualify if:

• Progression from prior palliative treatment with capecitabine- or docetaxel-based regimen
• Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer, diabetes or other contraindication for corticosteroid therapy
• Inability to take or absorb oral medicine
• Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
• Presence of neuropathy ≥grade 1 according to NCI-CTCAE V4.0
• Hypersensitivity or known or suspicious allergic to any of the study drugs
• Pregnant or lactated women
• Unsuitable for the study or other chemotherapy determined by investigator

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (7)

The Fourth Hospital of Anshan

Anshan, Liaoning, China

Location

The First Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The First Hospital of Liaoning Medical University

Jinzhou, Liaoning, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Liaoning Tumor Hospital

Shenyang, Liaoning, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Docetaxel; Injections

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yunpeng Liu, MD., PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

• Xiujuan Qu, MD.,PhD.

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.,PhD

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 23, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

CN (7)