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Clinical Trials/EUCTR2004-001904-10-EE
EUCTR2004-001904-10-EE
Active, not recruiting
Not Applicable

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.

Pierre Fabre Medicament represented by IRPF0 sites350 target enrollmentSeptember 2, 2005
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ConditionsTreatment in locally advanced or metastatic non-small-lung cancer.
DrugsNavelbine soft capsulesNavelbineTaxotereCisplatin EBEWE

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Treatment in locally advanced or metastatic non-small-lung cancer.
Sponsor
Pierre Fabre Medicament represented by IRPF
Enrollment
350
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 2, 2005
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Pierre Fabre Medicament represented by IRPF

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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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.
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