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

Primary Purpose

Docetaxel, Oxaliplatin and Fluorouracil

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Docetaxel, Oxaliplatin and 5-Fu

About this trial

This is an interventional treatment trial for Docetaxel, Oxaliplatin and Fluorouracil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Sixth Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel, Oxaliplatin and 5-Fu

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Response rate

Full Information

NCT ID

NCT02289378

First Posted

November 7, 2014

Last Updated

November 13, 2014

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02289378

Brief Title

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

Acronym

DaeMon-Plus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Docetaxel, Oxaliplatin and Fluorouracil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel, Oxaliplatin and 5-Fu

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel, Oxaliplatin and 5-Fu

Intervention Description

To investigate the triplet regimen in the first-line therapy of advanced chemotherapy

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Response rate

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Xiao, MD

xiao_jian@139.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yonghe Chen, MD

177243303@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping Lan, MD

Organizational Affiliation

The Sixth Affilated Hospital of Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

The Sixth Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Xiao, Ph D

Phone

86-2038250745

xiao_jian@139.com

First Name & Middle Initial & Last Name & Degree

Ping Lan, Ph D

12. IPD Sharing Statement

Learn more about this trial

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

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