NCT00174629CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 449
- Locations
- 1
- Primary Endpoint
- Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
1
Experimental
Intervention: docetaxel/gemcitabine (Drug)
2
Active Comparator
Intervention: Docetaxel/DDP (Drug)
Outcomes
Primary Outcomes
Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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