Weekly Docetaxel and Four Weekly Carboplatin in Non-small... | NCT00826852

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

NCT00826852

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 27, 2010Estimated

Enrollment

49Actual

Phase

Phase 2

Conditions

Lung Neoplasms

Interventions

docetaxel and carboplatin

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Oct 13, 2008

First Submission Date that Met QC Criteria

Jan 21, 2009

First Posted Date

Jan 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2010

Last Update Posted Date

Jul 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Name	Type	Description	Arm Group Labels	Other Names
docetaxel and carboplatin	Drug	weekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5

Measure	Description	Time Frame
Efficacy by response rate		After the 3rd cycle, 6th cycle and at every follow up visit

Measure	Description	Time Frame
Adverse events		At each visit
Efficacy by time to progression		Until the progression of all patients
Overall survival

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic