Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer (DaeMon-Plus)

November 13, 2014 updated by: Lan Ping, Sixth Affiliated Hospital, Sun Yat-sen University
This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The sixth affiliated hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent
  • Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
  • Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
  • At least 3 weeks since last major surgery
  • At least 12 months since last adjuvant chemotherapy
  • At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
  • Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
  • Patients with reproductive potential must use effective BC
  • Required Screening Laboratory Criteria:

Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min

  • A probable life expectancy of at least 6 months

Exclusion Criteria:

  • Brain metastases
  • Female of childbearing potential, pregnancy test is positive
  • Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
  • Active infection
  • Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
  • Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
  • History of grade 3 or 4 toxicity to fluoropyrimidines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel, Oxaliplatin and 5-Fu
Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks
Drug: Docetaxel, Oxaliplatin and 5-Fu
To investigate the triplet regimen in the first-line therapy of advanced chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Study Chair: Ping Lan, MD, The Sixth Affilated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DaeMon Plus

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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