Prospective randomised clinical phase III trial of (alternating IV and oral) vinorelbine plus cisplatin versus docetaxel plus cisplatin in first line chemotherapy of locally advanced or metastatic non-small-cell lung cnacer patients.

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2004-001904-10-AT
• Date of registration: 08/11/2004
• Prospective Registration: No
• Primary sponsor: Pierre Fabre Médicament represented by IRPF
• Public title: Prospective randomised clinical phase III trial of (alternating IV and oral) vinorelbine plus cisplatin versus docetaxel plus cisplatin in first line chemotherapy of locally advanced or metastatic non-small-cell lung cnacer patients.
• Scientific title: Prospective randomised clinical phase III trial of (alternating IV and oral) vinorelbine plus cisplatin versus docetaxel plus cisplatin in first line chemotherapy of locally advanced or metastatic non-small-cell lung cnacer patients.
• Date of first enrolment: 15/09/2004
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001904-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Estonia

Key inclusion & exclusion criteria

Inclusion criteria:
- Between 18 years and 75 years
- Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer, stage IIIB (with supra-clavicular or nodal metastases or pleural effusion), stage IV or relapsing (locally or distant) after a local treatment
- Karnofsky Performance Status not less than 80%
- Life expectancy not less than 12 weeks
- Previously untreated with chemotherapy or immunotherapy
- Adequate bone marrow, hepatic and renal functions
- Presence of at least one measurable indicator lesion (RECIST criteria) which has not been previously irradiated.
Are the trial subjects under 18?
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 with a local relapse to be treated by radiation therapy only
- Symptomatic neuropathy (sensory) not less than 1 according to the NCI Common Toxicity Criteria
- Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease)
- Active central nervous disorder, brain metastasis or leptomeningeal involvment
- Weight loss not less than 10% within the previous 3 months
- Superior vena cava syndrome
- Long term oxygen therapy
- Pre-existing symptomatic pleural effusion requiring tapping
- Ascites or pericardial effusion
- Radiotherapy within the previous 4 weeks
- Previous radiotherapy in the only site used to assess response
- Concomitant treatment with any other anticancer drug
- Known hypersensitivity to drugs with similar chemical structures of study drugs
- Concomitant treatment with corticosteroids except chronic treatment lasting more than 1 month, given at low doses (not less than 20mg/day of methylprednisolone or equivalent)
- Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
- Pregnant or breast-feeding women


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

Health Condition(s) or Problem(s) studied

Treatment in locally advanced or metastatic non-small-lung cancer.

Intervention(s)

Trade Name: Navelbine Soft Capsules
Product Name: Navelbine Soft Capsules
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20 (27.70)-30 (41.55)

Trade Name: I.V. Vinorelbine
Product Name: I.V. Vinorelbine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vinorelbine tartrate
CAS Number: 125317-39-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 10-

Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-80

Trade Name: Cisplatin
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
Concentration number: Commercial-

Primary Outcome(s)

Primary end point(s): Comparative evaluation of the Time to Treatment Failure (TTF) for both regimens.

Secondary Objective: To evaluate the response rate, the progression free survival and overall survival in both arms.
To evaluate the tolerance in both arms.
To assess clinical benefit and to evaluate QOL using LCSS in both arms.

Main Objective: To compare time to Treatment Failure (TTF) for both regimens

Secondary ID(s)

PM0259CA301J1