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

NCT ID: NCT01967875

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-05-31

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

Detailed Description

This is a prospective, multi-center, randomized control clinical trial, aimed to demonstrate if ERCC1 expression could predict the efficacy of platinum-based chemotherapy in patients with locally advanced or metastatic gastric cancer. A total of 180 patients are planned to be enrolled into the study. ERCC1 protein expression in paraffin-embedding tumor tissue is examined by immunohistochemistry (IHC). Patients with low ERCC1 expression (group L) will be treated with XP regimen. Patients with high ERCC1 expression will be randomized into group H-A or group H-B, and be treated with XP or DX regimen, respectively. The primary end point is progression free survival (PFS), and the secondary end points include the median overall survival, objective response rate (ORR),disease control rate(DCR), duration of response, safety(number and degree of adverse events), and the quality of life (QOL).

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

H-A: ERCC1 High Expression Group A

XP：Capecitabine+Cisplatin

Group Type: ACTIVE_COMPARATOR

Capecitabine+Cisplatin

Intervention Type: 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.

H-B: ERCC1 High Expression Group B

DX：Docetaxel+Capecitabine

Group Type: EXPERIMENTAL

Docetaxel+Capecitabine

Intervention Type: 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.

L: ERCC1 Low Expression Group

XP：Capecitabine+Cisplatin

Group Type: ACTIVE_COMPARATOR

Capecitabine+Cisplatin

Intervention Type: 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.

Interventions

Capecitabine+Cisplatin

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.

Intervention Type: DRUG

Docetaxel+Capecitabine

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.

Intervention Type: DRUG

Other Intervention Names

Xeloda; Docetaxel for injection; Xeloda

Eligibility Criteria

Inclusion Criteria

• 18y≤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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yunpeng Liu

MD.,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunpeng Liu, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Xiujuan Qu, MD.,PhD.

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

The Fourth Hospital of Anshan

Anshan, Liaoning, China

The First Hospital of Dalian Medical University

Dalian, Liaoning, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

The First Hospital of Liaoning Medical University

Jinzhou, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Tumor Hospital

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

CLOG1301

Identifier Type: -

Identifier Source: org_study_id