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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

Phase 3
18 Years
Not Enrolling
Lung Neoplasms

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Trial Information

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

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

- 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

- 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

Exclusion Criteria:

- pregnant or lactating women (women of childbearing potential must use adequate

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.

Principal Investigator

Jean-Philippe Aussel

Investigator Role:

Study Director

Investigator Affiliation:



Spain: Spanish Agency of Medicines

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Lung Neoplasms
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion, Malignant