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

Lung Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826852
• Other study ID #: XRP6976B_6020
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2008
• Last updated: July 26, 2010
• Start date: October 2003
• Est. completion date: July 2009

Study information

• Verified date: July 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• docetaxel and carboplatin
weekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5

Locations

Country	Name	City	State
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy by response rate		After the 3rd cycle, 6th cycle and at every follow up visit	No
Secondary	Adverse events		At each visit	No
Secondary	Efficacy by time to progression		Until the progression of all patients	No
Secondary	Overall survival		At the end of the study	No