Weekly Docetaxel and Four Weekly Carboplatin in Non-small Cell Lung Cancer Carbo-Tax

Sanofi

Status and phase

Completed

Phase 2

Conditions

Lung Neoplasms

Treatments

Drug: docetaxel and carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

XRP6976B_6020

Details and patient eligibility

About

The purpose of this study is:

to assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate
to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time.

Enrollment

49 patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer
ECOG Performance Status is 0-2
At least one measurable lesion in two dimensions by means of CT scan
No brain metastases
No prior chemotherapy for this malignancy,
Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours urine ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 2.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)

Exclusion criteria

Concomitant use of another anti-cancer therapy
Chemotherapy, radiotherapy or curative surgery
Evidence of intracerebral metastasis
Unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis.
Presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years.
Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
Social or psychological condition that render the patient inadequate for the follow-up of the study
Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.