Study of Weekly DCF to Treat Advanced Gastric Cancer

This study has been terminated.
(The study has finished.)
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00568971
First received: December 5, 2007
Last updated: January 26, 2010
Last verified: August 2009

December 5, 2007
January 26, 2010
April 2007
June 2008   (final data collection date for primary outcome measure)
Response rate, overall survival [ Time Frame: 2-6 months ] [ Designated as safety issue: Yes ]
Efficacy [ Time Frame: every two cycles ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00568971 on ClinicalTrials.gov Archive Site
Side effects [ Time Frame: 2-6 month ] [ Designated as safety issue: Yes ]
Side effects [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Weekly DCF to Treat Advanced Gastric Cancer
Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer

The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC.

Recently,in a multi-center, open-label randomized phase III study (V325), compared to the control arm of CF regimen, DCF showed higher efficacy in terms of response rate, time to progression and overall survival. But the regimen had increased grade 3-4 neutropenia (82% vs 57%) and febrile neutropenia infection (29% vs 12%). We began to study on weekly DCF in the patients with advanced gastric cancer to evaluate the efficacy no less than that of 3-week' regimen.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
Drug: Docetaxel, Cisplatin, 5-Fu
Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
Other Name: wDCF
Experimental: weekly chemo
Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
Intervention: Drug: Docetaxel, Cisplatin, 5-Fu
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 70 years
  • Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
  • ECOG performance status ≤1,life expectancy more than 3 months,
  • Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
  • Measurable disease according to the RECIST.

Exclusion Criteria:

  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
  • The evidence of CNS metastasis
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Received other chemotherapy regimen after metastasis
  • Used taxane in adjuvant settings
  • Participated in other clinical trials.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00568971
DCF-AGC
No
Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
Fudan University
Not Provided
Principal Investigator: Jin Li, PhD Fudan University
Fudan University
August 2009

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