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Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer

Phase 2
18 Years
70 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate, overall survival

Outcome Time Frame:

2-6 months

Safety Issue:


Principal Investigator

Jin Li, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

  • Gastric Cancer
  • DCF
  • Advanced gastric cancer
  • Phase II study
  • Efficacy
  • Toxicity
  • Stomach Neoplasms