Study of Weekly DCF to Treat Advanced Gastric Cancer

Fudan University

Status and phase: Terminated; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Docetaxel, Cisplatin, 5-Fu

Study type: Interventional

Funder types: Other

Identifiers

NCT00568971

DCF-AGC

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

weekly chemo

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel, Cisplatin, 5-Fu