Docetaxel in Locally Advanced Gastric Adenocarcinoma

Stomach Neoplasms Clinical Trial

— NEOTAX  

Official title:

Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343239
• Other study ID #: DOCET_L_00072
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2006
• Last updated: November 3, 2014
• Start date: June 2006
• Est. completion date: March 2012

Study information

• Verified date: November 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Study objectives:

To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically proven gastric adenocarcinoma diagnosis

• Selected Stage IIB (T3N0M0), Stage IIIA (T2aN2M0, T2bN2M0, T3N1M0, T4N0M0), Stage IIIB (T3N2M0) and selected Stage IV (all T4 , NM0, all TN3M0's). Clinical staging performed with endoscopic ultrasound and CT. Laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement.

• ECOG performance status between 0 and 2

• Acceptable hematological profile :

• WBC (White Blood Cell) count =4000/mm3

• Platelet count =100 000 mm3

• Hemoglobin =9 g/100 mL (if lower, may be included following transfusion)

• Adequate renal function

• Serum creatinine <1.2 mg/dl or calculated creatinine clearance in 24-hours urine >60 mL/min.

• Adequate hepatic function

• Bilirubin < UNL

• Transaminases (ALT, AST) <2.5 x UNL

• Alcaline phosphatase <2.5 x UNL

• Adequate pulmonary function

• Adequate cardiac function

• No prior chemotherapy for gastric cancer

Exclusion Criteria:

• Other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma

• Pregnant or lactating patients

• Patients with brain, bone or other metastases; peritoneal involvement

• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry

• Previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years

• Active infection and other serious disease

• Any other experimental drugs within a 4-week period prior to the study

• Contraindications for the use of any study drug (e.g. history of hypersensitivity to the contents of the study drugs)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel
Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2
• Cisplatin
Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2
• Fluorouracil
Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 750 mg/m2/day for 5 days

Locations

Country	Name	City	State
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ozdemir N, Abali H, Vural M, Yalcin S, Oksuzoglu B, Civelek B, Oguz D, Bostanci B, Yalcin B, Zengin N. Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.		3 cycles	No