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Docetaxel in Locally Advanced Gastric Adenocarcinoma (NEOTAX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00343239
First received: June 21, 2006
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

Study objectives:

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


Condition Intervention Phase
Stomach Neoplasms
Drug: Docetaxel
Drug: Cisplatin
Drug: Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination. [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: June 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343239

Locations
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Edibe Taylan Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00343239     History of Changes
Other Study ID Numbers: DOCET_L_00072
Study First Received: June 21, 2006
Last Updated: November 3, 2014
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Cisplatin
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014