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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by China Medical University, China
Sponsor:
Information provided by (Responsible Party):
Yunpeng Liu, China Medical University, China
ClinicalTrials.gov Identifier:
NCT01967875
First received: October 15, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Stomach Neoplasms
Drug: Capecitabine+Cisplatin
Drug: Docetaxel+Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized Control 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

Resource links provided by NLM:


Further study details as provided by China Medical University, China:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival(OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Objective Response Rate(ORR),Including Complete Response(CR) and Partial Response(PR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disease Control Rate(DCR), Including Complete Response(CR) , Partial Response(PR) and Stable Disease(SD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety(number and degree of adverse events) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Quality of Life(QOL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: July 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: H-A: ERCC1 High Expression Group A
XP:Capecitabine+Cisplatin
Drug: 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.
Other Name: Xeloda
Experimental: H-B: ERCC1 High Expression Group B
DX:Docetaxel+Capecitabine
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.
Other Names:
  • Docetaxel for injection
  • Xeloda
Active Comparator: L: ERCC1 Low Expression Group
XP:Capecitabine+Cisplatin
Drug: 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.
Other Name: Xeloda

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967875

Contacts
Contact: Yunpeng Liu, MD.,PhD +86-24-83282312 cmuliuyunpeng@hotmail.com
Contact: Jing Liu, MD. +86-24-83282542 liujing_cmu@hotmail.com

Locations
China, Liaoning
The Fourth Hospital of Anshan Not yet recruiting
Anshan, Liaoning, China
The First Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China
The Second Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China
The First Hospital of Liaoning Medical University Not yet recruiting
Jinzhou, Liaoning, China
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Yunpeng Liu, MD., PhD.    86-24-83282312    cmuliuyunpeng@hotmail.com   
Shengjing Hospital of China Medical University Not yet recruiting
Shenyang, Liaoning, China
Liaoning Tumor Hospital Not yet recruiting
Shenyang, Liaoning, China
Sponsors and Collaborators
China Medical University, China
Investigators
Principal Investigator: Yunpeng Liu, MD., PhD China Medical University, China
Principal Investigator: Xiujuan Qu, MD.,PhD. China Medical University, China
  More Information

No publications provided

Responsible Party: Yunpeng Liu, MD.,PhD, China Medical University, China
ClinicalTrials.gov Identifier: NCT01967875     History of Changes
Other Study ID Numbers: CLOG1301
Study First Received: October 15, 2013
Last Updated: October 18, 2013
Health Authority: China: Ethics Committee

Keywords provided by China Medical University, China:
Gastric Cancer
ERCC1
Platinum
Chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014