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Docetaxel in Locally Advanced Gastric Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00343239
First received: June 21, 2006
Last updated: April 2, 2012
Last verified: April 2012
History of Changes

June 21, 2006
April 2, 2012
June 2006
March 2012   (final data collection date for primary outcome measure)
To determine the Ro resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination. [ Time Frame: Follow-up time ] [ Designated as safety issue: No ]
To determine the Ro resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, cisplatin, florouracil combination
Complete list of historical versions of study NCT00343239 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Docetaxel in Locally Advanced Gastric Adenocarcinoma
Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study

Study objectives:

To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
Drug: Docetaxel
Docetaxel, cisplatin and fluorouracil combination
Experimental: 1
docetaxel
Intervention: Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00343239
DOCET_L_00072
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Edibe Taylan Sanofi
Sanofi
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP