GILT Docetaxel - Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Open-Label, Cooperative, Randomized, Multicenter Phase III Study on the Use of Cisplatin Resistant Genotype (ERCC1 Over-Expression) in Tumor RNA to Customize Chemotherapy in Stage IV-IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer Patients

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: Docetaxel/DDP
* Drug: docetaxel/gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: docetaxel/gemcitabine<br> <br> |
| Active Comparator: 2<br> | Drug: Docetaxel/DDP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |