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Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer

NCT02004769 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2016-11-18

No results posted yet for this study

Summary

Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease are to be recruited in the study. In the current study, the efficacy and safety of Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate precision rather than controlling type I\&II error. Assuming the target PFS is 6.7m, 60 patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will be enrolled.

Conditions

  • Stomach Neoplasms
  • Neoplasms Metastasis
  • ERBB2 Gene Amplification

Interventions

DRUG

Trastuzumab

Trastuzumab (Herceptin) will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks (q3w), until disease progress or intolerable toxicity.

DRUG

Docetaxel

Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.

DRUG

Capecitabine

Capecitabine (Xeloda) 2000mg/m2d, d1-14, every 3 weeks until disease progress or intolerable toxicity.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • 307 Hospital of PLA

    collaborator OTHER

  • Shandong Tumor Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Second Affiliated Hospital of Suzhou University

    collaborator OTHER

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ruihua Xu, M.D,Ph.D · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004769 on ClinicalTrials.gov