A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)

Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country39 target enrollmentMarch 2012

ConditionsGastric Adenocarcinoma

DrugsDocetaxel Fluorouracil

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Gastric Adenocarcinoma
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment: 39
Locations: 1
Primary Endpoint: Overall response rate according to RECIST 1.1
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party

Principal Investigator

Jian Xiao

Principal Investigator

Sixth Affiliated Hospital, Sun Yat-sen University

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

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