Overview

GILT Docetaxel - Non-Small Cell Lung Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Docetaxel
Gemcitabine
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.