Docetaxel in Locally Advanced Gastric Adenocarcinoma

Phase 2

Completed

• Conditions: Stomach Neoplasms
• Interventions: Drug: Docetaxel; Drug: Cisplatin; Drug: Fluorouracil

• Registration Number: NCT00343239
• Lead Sponsor: Sanofi

Brief Summary

Study objectives:

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-21
• Study First Submitted QC: 2006-06-21
• Study First Posted: 2006-06-22
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetaxel/Cisplatin/Fluorouracil (DCF)	Docetaxel	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
Docetaxel/Cisplatin/Fluorouracil (DCF)	Cisplatin	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
Docetaxel/Cisplatin/Fluorouracil (DCF)	Fluorouracil	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey