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

Primary Purpose

Lung Neoplasms

Status

Completed

Phase

Phase 2

Locations

Turkey

Study Type

Interventional

Intervention

docetaxel and carboplatin

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

Efficacy by response rate

Secondary Outcome Measures

Adverse events

Efficacy by time to progression

Overall survival

Full Information

NCT ID

NCT00826852

First Posted

October 13, 2008

Last Updated

July 26, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00826852

Brief Title

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

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel and carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy by response rate

Time Frame

After the 3rd cycle, 6th cycle and at every follow up visit

Secondary Outcome Measure Information:

Title

Adverse events

Time Frame

At each visit

Title

Efficacy by time to progression

Time Frame

Until the progression of all patients

Title

Overall survival

Time Frame

At the end of the study

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edibe Taylan, MD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Istanbul

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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