Docetaxel in Locally Advanced Gastric Adenocarcinoma

NCT ID: NCT00343239

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2012-03-31

Brief Summary

Study objectives:

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

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Formulation: infusion solution

Route of administration: IV infusion on the first day of each 21-day cycle

Dose regimen: 75 mg/m2

Cisplatin

Intervention Type: DRUG

Formulation: infusion solution

Route of administration: IV infusion on the first day of each 21-day cycle

Dose regimen: 75 mg/m2

Fluorouracil

Intervention Type: DRUG

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

Interventions

Docetaxel

Formulation: infusion solution

Route of administration: IV infusion on the first day of each 21-day cycle

Dose regimen: 75 mg/m2

Intervention Type: DRUG

Cisplatin

Formulation: infusion solution

Route of administration: IV infusion on the first day of each 21-day cycle

Dose regimen: 75 mg/m2

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edibe Taylan

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ozdemir N, Abali H, Vural M, Yalcin S, Oksuzoglu B, Civelek B, Oguz D, Bostanci B, Yalcin B, Zengin N. Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX study. Cancer Chemother Pharmacol. 2014 Dec;74(6):1139-47. doi: 10.1007/s00280-014-2586-6. Epub 2014 Sep 19.

Reference Type: RESULT

PMID: 25234436 (View on PubMed)

Other Identifiers

DOCET_L_00072

Identifier Type: -

Identifier Source: org_study_id