GILT Docetaxel - Non-Small Cell Lung Cancer

NCT ID: NCT00174629

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30

Brief Summary

Primary Objective:

• To compare response rate between genotypic groups and control group.

Secondary Objective:

• To determine the safety, time to treatment failure and survival in control and genotypic arms.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

docetaxel/gemcitabine

Intervention Type: DRUG

2

Group Type: ACTIVE_COMPARATOR

Docetaxel/DDP

Intervention Type: DRUG

Interventions

Docetaxel/DDP

Intervention Type: DRUG

docetaxel/gemcitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients must be/have:

• histologically confirmed non-small cell lung cancer (squamous cell carcinoma, large cells or adenocarcinoma; it is recommended to provide the full paraffin-embedded block or at least 5 5 sections obtained from the primary tumor, recurrence or metastasis, not stained, fixed in formalin/embedded in paraffin, mounted on slides (10 micron sections), as well as two serum samples in two 10-ml tubes and two blood samples (see appendix X);
• unresectable metastatic (stage IV or IIIB malignant pleural effusion) NSCLC;
• WHO performance status < 2;
• Adequate bone marrow, hepatic and renal functions, assessed during the previous 14 days, that should be shown by the following characteristics:

• hemoglobin > or = 10g/dl and no blood cell transfusion within the previous 2 weeks;
• absolute neutrophil count > 2.0 10^9 cells/l;
• platelet count > or = 100.10^9 cells/l;
• no evidence of myelodysplastic syndrome or abnormal bone marrow reserve;
• creatinine < or = 1.5 x UNL or creatinine clearance > or = 60 ml/min (real or calculated);
• total bilirubin < or = UNL;
• ASAT (SGOT) and/or ALAT (SGPT) < or = 1.5 x UNL;
• alkaline phosphatases < or = 5 x UNL;
• serum calcium < or = 1.1 x UNL;
• at least one measurable lesion;
• previous surgery intervention (more than 30 days before inclusion in the study) is allowed but metastatic disease must be demonstrated;
• previous radiotherapy is allowed if:

• less or equal to 10% of bone marrow has been irradiated
• end of radiotherapy 21 days or more prior to inclusion in the study;
• patient has fully recovered from all toxic effects;
• at least one of the measurable target lesions for evaluation of tumor response has not been irradiated;
• the patient must be accessible for treatment and follow-up. The patient entered into this trial must be treated and followed up at the participating center;
• life expectancy > or = 12 weeks;
• The initial diagnostic procedures should be performed during the 4 weeks prior to the randomization.

Exclusion Criteria

• pregnant or lactating women (women of childbearing potential must use adequate contraception);
• prior systemic chemotherapy or immunotherapy for NSCLC, even as neoadjuvant or adjuvant therapy;
• prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 5 years;
• history or clinical symptomatic brain or leptomeningeal metastases;
• current peripheral neuropathy and neurohearing > or = NCIC-CTG grade 2 except if due to trauma;
• other serious illness or medical condition, including:

• congestive heart disease; prior myocardial infarction within 6 months;
• history of significant neurologic or psychiatric disorders that would inhibit their understanding and giving of informed consent;
• infection requiring I.V. antibiotics and tuberculosis under treatment ongoing at study entry;
• untreated superior vena cava syndrome;
• active peptic ulcer; unstable diabetes mellitus or other contraindication to high dose corticotherapy such as herpes, herpes zoster, cirrhosis;
• hypercalcemia requiring therapy;
• preexisting ascitis and/or clinical significant pericardial effusion;
• patients whose lesion(s) are assessable only by radionuclide scan;
• history of allergy to drugs containing the excipient TWEEN 80®;
• concurrent treatment with other investigational drugs;
• participation in a clinical trial of one or more investigational agents (i.e. antibiotic) or devices within 30 days of study entry.

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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Jean-Philippe Aussel

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Berlin, , Germany

Sanofi-Aventis

Barcelona, , Spain

Sanofi-Aventis

Geneva, , Switzerland

Countries

Germany; Spain; Switzerland

Other Identifiers

TAX_ES1_302

Identifier Type: -

Identifier Source: org_study_id