Study of Weekly DCF to Treat Advanced Gastric Cancer

NCT00568971 | Terminated Phase 2

• 1 other identifier: DCF-AGC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response rate, overall survival

  2-6 months

Secondary Outcomes (1)

• Side effects

  2-6 month

Study Arms (1)

weekly chemo

EXPERIMENTAL

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

Interventions

Docetaxel, Cisplatin, 5-Fu DRUG

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.

Also known as: wDCF

weekly chemo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jin Li, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 27, 2010

Record last verified: 2009-08

Locations

CN (1)