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

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

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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: At each visit ]
  • Efficacy by time to progression [ Time Frame: Until the progression of all patients ]
  • Overall survival [ Time Frame: At the end of the study ]

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

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00826852

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

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017