NEOTAX: Docetaxel in Locally Advanced Gastric Adenocarcinoma

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00343239

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study objectives:

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

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Drug: Docetaxel Drug: Cisplatin Drug: Fluorouracil	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Docetaxel/Cisplatin/Fluorouracil (DCF) DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability	Drug: Docetaxel Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2 Drug: Cisplatin Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2 Drug: 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

Arm

Intervention/Treatment

Experimental: Docetaxel/Cisplatin/Fluorouracil (DCF)

DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability

Drug: Docetaxel

Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2

Drug: Cisplatin

Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2

Drug: 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

Outcome Measures

Primary Outcome Measures

To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination. [3 cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Istanbul		Turkey

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Edibe Taylan, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT00343239

Other Study ID Numbers:

DOCET_L_00072

First Posted:

Jun 22, 2006

Last Update Posted:

Nov 4, 2014

Last Verified:

Nov 1, 2014

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2014