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

NCT00826852 | Completed Phase 2

• 1 other identifier: XRP6976B_6020
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Efficacy by response rate

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

Secondary Outcomes (3)

• Adverse events

  At each visit

• Efficacy by time to progression

  Until the progression of all patients

• Overall survival

  At the end of the study

Interventions

docetaxel and carboplatin DRUG

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

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Edibe Taylan, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: January 22, 2009
• Study Start: October 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 27, 2010

Record last verified: 2010-07

Locations

TU (1)