GILT Docetaxel - Non-Small Cell Lung Cancer

Sanofi

Status and phase: Completed; Phase 3

Conditions: Lung Neoplasms

Treatments: Drug: Docetaxel/DDP; Drug: docetaxel/gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174629

TAX_ES1_302

Details and patient eligibility

About

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.

Enrollment: 449 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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449 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: docetaxel/gemcitabine

2

Active Comparator group

Treatment:

Drug: Docetaxel/DDP