Clinical trial NCT00826852: Weekly Docetaxel and Four Weekly Carboplatin in Non-small Cell Lung Cancer Carbo-Tax
Official title: Phase II Trial of Weekly Docetaxel and Four Weekly Carboplatin Combination in the First-line Treatment of Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 49
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy by response rate
timeFrame: After the 3rd cycle, 6th cycle and at every follow up visit
Secondary outcomes:
measure: Adverse events
timeFrame: At each visit
measure: Efficacy by time to progression
timeFrame: Until the progression of all patients
measure: Overall survival
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Edibe Taylan, MD
role: STUDY_DIRECTOR
References: