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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00826852
First received: October 13, 2008
Last updated: July 26, 2010
Last verified: July 2010
  Purpose

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.

Condition Intervention Phase
Lung Neoplasms
Drug: docetaxel and carboplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy by response rate [ Time Frame: After the 3rd cycle, 6th cycle and at every follow up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: At each visit ] [ Designated as safety issue: No ]
  • Efficacy by time to progression [ Time Frame: Until the progression of all patients ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: October 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: docetaxel and carboplatin
    weekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826852

Locations
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Edibe Taylan, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi aventis
ClinicalTrials.gov Identifier: NCT00826852     History of Changes
Other Study ID Numbers: XRP6976B_6020
Study First Received: October 13, 2008
Last Updated: July 26, 2010
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014