Study of Weekly DCF to Treat Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00568971
• Other study ID #: DCF-AGC
• Status: Terminated
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: January 26, 2010
• Start date: April 2007
• Est. completion date: June 2008

Study information

• Verified date: August 2009
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate, overall survival		2-6 months	Yes
Secondary	Side effects		2-6 month	Yes