Efficacy and Safety Study of Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was  Recruiting
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: March 28, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Gastric Adenocarcinoma
Drug: Docetaxel
Drug: Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)

Resource links provided by NLM:


Further study details as provided by Sixth Affiliated Hospital, Sun Yat-sen University:

Primary Outcome Measures:
  • Overall response rate according to RECIST 1.1 [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: March 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

Primary endpoint: Overall Response Rate

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567618

Contacts
Contact: Yue Cai, Master 86-20-38250745 chilly8518@163.com

Locations
China, Guangdong
Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yue Cai    86-20-38250745    chilly8518@163.com   
Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yue Cai    86-20-38250745    chilly8518@163.com   
Principal Investigator: Jian Xiao         
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Jian Xiao, Principal Investigator, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01567618     History of Changes
Other Study ID Numbers: SAHMO-04
Study First Received: March 27, 2012
Last Updated: March 28, 2012
Health Authority: China: Ethics Committee

Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
Docetaxel
Fluorouracil
First line therapy
Gastric cancer

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Fluorouracil
Docetaxel
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 25, 2014