A randomized phase II study of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. - GATE (GAstric cancer study with Taxotere-Eloxatin-based regimens)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005464-92-BE
• Date of registration: 15/06/2006
• Prospective Registration: Yes
• Primary sponsor: Sanofi-aventis groupe
• Public title: A randomized phase II study of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. - GATE (GAstric cancer study with Taxotere-Eloxatin-based regimens)
• Scientific title: A randomized phase II study of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. - GATE (GAstric cancer study with Taxotere-Eloxatin-based regimens)
• Date of first enrolment: 19/07/2006
• Target sample size: 270
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005464-92
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Germany, Hungary, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1.Patient’s consent form obtained, signed and dated before beginning specific protocol procedures.
2.Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction,
3.Metastatic or locally recurrent disease
4.Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-FU, CDDP, epirubicin is allowed provided that the patient has relapsed > 12 months after the end of the chemotherapy.
5.At least 4 weeks from prior radiotherapy for palliation of metastases and 3 weeks from surgery.
6.Patient age = 18
7.Performance status Karnofsky index > 70
8.Hematology within 7 days before randomization:
Hb =10g/dl, ANC =2.0 109/L, platelets =100 x 109/L
9.Blood chemistry within 7 days before randomization:
Total bilirubin =1x UNL,
AST (SGOT) and ALT (SGPT) =2.5xUNL, alkaline phosphatase = 5x UNL, provided that AST or ALT > 1.5 x UNL is not associated with alkaline phosphatase > 2.5 x UNL; creatinine =1.25x UNL or =120 µmol/l and calculated / measured creatinine clearance =60 ml/min)
10.Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally reccurrent disease is accepted provided that there is at least one measurable lesion (e.g. lymph node).
11.Complete initial tumor work-up within two three weeks prior to randomization. Chest X-ray and/or Chest CT/MRI scan, and abdominal/ abdomino-pelvic CT/MRI scan are mandatory. Bone scan should be done if clinically indicated.
12.Patients must be able to comply with treatment, management of toxicity and scheduled follow-up in the participating centers

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients will be excluded from this study if they meet any of the following criteria:
1.Other tumor type than adenocarcinoma
2.Any prior palliative chemotherapy.
3.Any prior adjuvant (and/or neo-adjuvant) chemotherapy other than those specified in inclusion criterion #4.
4.No prior Taxotere® or Eloxatin® or Xeloda®
5.Neurosensory symptoms NCI-CTCAE grade=2
6.Prior radiotherapy other than (neo) adjuvant. In case of (neo)adjuvant radiotherapy, the relapse must be outside the radiotherapy fields
7.Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer
8.Other serious illness or medical conditions:
-unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry,
-history of significant neurologic or psychiatric disorders including dementia or seizures,
-active uncontrolled infection
-active disseminated intravascular coagulation,
-other serious underlying medical conditions which could impair the ability of the patient to participate in the study,
- intestinal occlusion / stenosis which impair their ability to take oral medications;
9.Known hypersensitivity to Taxotere® (or any drug formulated with Polysorbate-80), or Eloxatin® or Xeloda® or 5-FU;
10.Definite contraindications for the use of corticosteroids.
11.Concurrent treatment with corticosteroids (or equivalent) except pre-medication regimen (see section 8.3.2), treatment of acute hypersensitivity reactions or chronic treatment (initiated > 6 months prior to study entry) at low doses (< 20 mg methyl prednisolone or equivalent);
12.Concurrent treatment with any other anti-cancer therapy.
13.Hypercalcemia (> 12 mg/dl) not controlled by bisphosphonates ;
14.Patients with known brain or leptomeningeal metastases;
15.Any other experimental drugs within 4 week period prior to randomization and throughout the study period,
16.Pregnant or lactating woman;
17.Patients (M/F) with reproductive potential not implementing adequate contraceptive measures;
18.Patient is unable to comply with requirements of study;



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Metastatic or local recurrent gastric cancer previously untreated with chemotherapy for advance disease.
MedDRA version: 8.1 Classification code 10017758

Intervention(s)

Trade Name: Taxotere
Product Name: TAXOTERE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Trade Name: Xeloda 150 mg
Product Name: XELODA
Pharmaceutical Form: Tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Eloxatin 5 mg/ml
Product Name: ELOXATIN
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Oxaliplatine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: Xeloda 500mg
Product Name: XELODA
Pharmaceutical Form: Tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)

Main Objective: The primary objective of the study is to assess the time to progression (TTP) of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease.
The optimal doses to be used will be first determined in part I of the trial (pilot phase) by assessing the safety and tolerability of 2 dose levels in each arm.

Primary end point(s): Primary endpoint:
- Time to Progression

Secondary Objective: To establish the safety profile.
To assess the Overall Response Rate (ORR) (WHO criteria will be used)
To assess the overall survival (OS)

Secondary ID(s)

DOCOX-C-00082

2005-005464-92-ES