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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568971

Enrollment

Registered

2007-12-06

Start date

2007-04-30

Completion date

2008-06-30

Last updated

2010-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

DCF, Advanced gastric cancer, Phase II study, Efficacy, Toxicity

Brief summary

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

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.

Interventions

DRUGDocetaxel, 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Response rate, overall survival	2-6 months

Secondary

Measure	Time frame
Side effects	2-6 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026