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Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer (DaeMon)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01567618
First received: March 27, 2012
Last updated: November 6, 2014
Last verified: November 2014

March 27, 2012
November 6, 2014
March 2012
September 2013   (final data collection date for primary outcome measure)
Overall response rate according to RECIST 1.1 [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01567618 on ClinicalTrials.gov Archive Site
  • Time to progression [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Incidence of grade 3 or 4 toxicity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The criteria to grade the toxicity is NCI CTC 3.0
Same as current
Not Provided
Not Provided
 
Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)

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.

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Adenocarcinoma
  • Drug: Docetaxel

    Docetaxel 50mg/m2 iv drip, repeat every two weeks;

    Efficacy will be evaluated every three cycles.

  • Drug: Fluorouracil
    Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
April 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01567618
SAHMO-04
Yes
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
Sixth Affiliated Hospital, Sun Yat-sen University
Not Provided
Not Provided
Sixth Affiliated Hospital, Sun Yat-sen University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP