Status:
COMPLETED
GILT Docetaxel - Non-Small Cell Lung Cancer
Lead Sponsor:
Sanofi
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 genot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT00174629
Start Date
June 1 2001
Last Update
December 7 2009
Active Locations (3)
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1
Sanofi-Aventis
Berlin, Germany
2
Sanofi-Aventis
Barcelona, Spain
3
Sanofi-Aventis
Geneva, Switzerland