Docetaxel in Locally Advanced Gastric Adenocarcinoma (NEOTAX)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Drug: Cisplatin; Drug: Fluorouracil; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00343239

DOCET_L_00072

Details and patient eligibility

About

Study objectives:

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

Enrollment: 59 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Docetaxel/Cisplatin/Fluorouracil (DCF)

Experimental group

Description:

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

Treatment:

Drug: Cisplatin

Drug: Fluorouracil

Drug: Docetaxel