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
  Purpose

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


Condition Intervention Phase
Gastric Cancer
Drug: Docetaxel, Cisplatin, 5-Fu
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Response rate, overall survival [ Time Frame: 2-6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 2-6 month ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568971

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, PhD Fudan University
  More Information

No publications provided

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00568971     History of Changes
Other Study ID Numbers: DCF-AGC
Study First Received: December 5, 2007
Last Updated: January 26, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
DCF
Advanced gastric cancer
Phase II study
Efficacy
Toxicity

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014