Clinical trial NCT00174629: GILT Docetaxel - Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.
Secondary outcomes:
measure: Time to treatment failure and survival
timeFrame: calculated from the registration date until progression or death, respectively
measure: Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria.
timeFrame: before each cycle
measure: Adverse events not reported in NCIC-CTG Expanded Common Toxicity Criteria will be graded as mild, moderate, severe, and life threatening.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Sanofi-Aventis
city: Barcelona
country: Spain
facility: Sanofi-Aventis
city: Genève
country: Switzerland
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Jean-Philippe Aussel
role: STUDY_DIRECTOR
References: