Lung Neoplasms
Conditions
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.
Interventions
DRUGDocetaxel/DDP
DRUGdocetaxel/gemcitabine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure and survival | calculated from the registration date until progression or death, respectively |
| Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria. | before each cycle |
| Adverse events not reported in NCIC-CTG Expanded Common Toxicity Criteria will be graded as mild, moderate, severe, and life threatening. | Throughout the study |
Countries
Germany, Spain, Switzerland
Outcome results
None listed