Back to resultsDose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer (DaeMon)
Primary Purpose
Gastric Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring Docetaxel, Fluorouracil, First line therapy, Gastric cancer
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
Sites / Locations
- Sixth Affiliated Hospital of Sun Yat-sen University
Outcomes
Primary Outcome Measures
Overall response rate according to RECIST 1.1
Secondary Outcome Measures
Time to progression
Overall survival
Incidence of grade 3 or 4 toxicity
The criteria to grade the toxicity is NCI CTC 3.0
Full Information
NCT ID
NCT01567618
First Posted
March 27, 2012
Last Updated
November 6, 2014
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01567618
Brief Title
Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
Acronym
DaeMon
Official Title
A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
April 2014 (Actual)
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 and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.
Detailed Description
Primary endpoint: Overall Response Rate
Secondary endpoint: Time to progression, overall survival, safety data
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
Docetaxel, Fluorouracil, First line therapy, Gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 50mg/m2 iv drip, repeat every two weeks;
Efficacy will be evaluated every three cycles.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles
Primary Outcome Measure Information:
Title
Overall response rate according to RECIST 1.1
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
One year
Title
Overall survival
Time Frame
One year
Title
Incidence of grade 3 or 4 toxicity
Description
The criteria to grade the toxicity is NCI CTC 3.0
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
12. IPD Sharing Statement
Learn more about this trial
Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
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