Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Sanofi

Status and phase

Terminated

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00263016

XRP6976B_2503

Details and patient eligibility

About

Primary Objective:

To compare the tumour response rate of combination chemotherapy irinotecan/cisplatin (IC) versus docetaxel/cisplatin (DC) in advanced NSCLC patients who responded to 3 courses of docetaxel/cisplatin.

Secondary Objectives :

To compare the time to progression after chemotherapy treatment between the IC and DC arms of treatment.
To compare the toxicity profile of the IC and DC arms of treatment.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically proven non-small cell lung carcinoma at first diagnosis.
Stage IIIB or IV disease.
Tumour considered unresectable.
Performance status Karnofsky index > 60% or WHO performance status < or = 1.
Previous therapy
- Chemotherapy: None.
- Previous radiation therapy: prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal.
Laboratory requirements:
- Hematology:
  - Neutrophils ≥ 2.0 10^9/l,
  - Platelets ≥ 100 10^9/l,
  - Hemoglobin ≥ 10 g/dl.
- Hepatic function:Total bilirubin < 1 Upper Normal Limit (UNL), AST (SGOT) and ALT (SGPT) < 2.5 UNL,Alkaline phosphatase < 5 UNL ; except in presence of only bone metastasis and in absence of any liver disorders. Patients with AST and/or ALT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
- Renal function: Creatinine < 140 µmol/l (1.6 mg/dl) ; if limit values, the calculated creatinine clearance should be > 60 ml/min.

Exclusion criteria

Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.
Known clinical brain or leptomeningeal involvement.
Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by National Cancer Institute criteria.
Other serious illness or medical condition:
- Congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrhythmias.
- History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
- Active uncontrolled infection.
- Peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids.
Past or current history of neoplasm other than non-small cell lung cancer, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix.
Concurrent treatment with prednisone (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or unless chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent).
Definite contraindications for the use of corticosteroids.
Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
Concurrent treatment with any other anti-cancer therapy.