Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819728
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : January 11, 2011
Information provided by:

January 7, 2009
January 9, 2009
January 11, 2011
June 2000
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Complete list of historical versions of study NCT00819728 on Archive Site
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Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer
Multicenter Phase II Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer
The main purpose of the study is to determine the activity of the weekly combination of docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced, previously untreated, non-small cell lung cancer. It is also to determine the activity of this combination in terms of response duration, time to progression, median survival, overall survival, and percent one-year survival, as well as the side-effect and toxicity profile of weekly Taxotere and weekly irinotecan.
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Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: Docetaxel
    35mg/m2 IV each week for 4 weeks
    Other Name: Taxotere
  • Drug: Irinotecan
    50mg/m2 IV each week for 4 weeks
Experimental: Taxotere/Irinotecan
  • Drug: Docetaxel
  • Drug: Irinotecan
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2003
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Inclusion Criteria:

  • Microscopically or cytologically confirmed non-small cell lung cancer. Histology may include large cell, squamous cell, undifferentiated, or bronchioalveolar carcinoma, or adenocarcinoma, but no small cell or carcinoid.
  • Inoperable stage III B or metastatic stage IV NSCLC
  • Measurable (bidimensionally) indicator lesion(s) which have not been irradiated.
  • No prior systemic chemotherapy. Prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal or there must be radiologic proof of progressive disease. If a patient is receiving palliative radiation, other than the chest, to one site at 30 cGy or less, then the patient is eligible and chemotherapy can proceed immediately after palliative RT.
  • ECOG performance status 0 or 1 at screening and on the first day of treatment
  • Life expectancy = 12 weeks.
  • Patients must be > 4 weeks from prior radiation therapy to the pelvis, spine or long bones, and must be recovered from all side effects.
  • Patients must be > 3 weeks from prior major surgery, except for a simple biopsy or placement of a venous access device.

Exclusion Criteria:

  • No patient may have the following:
  • Neutrophils < 1,500/mm3.
  • Platelets < 100,000/mm3.
  • Serum creatinine >1.8 mg/dL.
  • SGOT > 1.5 times the upper limit of normal for institution.
  • Total bilirubin > the upper limit of normal for institution.
  • Alkaline phosphatase > 5 times the upper limit of normal for institution.
  • Pregnant or lactating females or females of childbearing potential not employing adequate contraception.
  • History of other malignancy within the last five years which could affect the diagnosis of NSCLC, except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Current metastatic CNS disease, if present, must have been treated and clinically stable for at least 3 weeks prior to initial Taxotere treatment. Patients with documented meningeal carcinomatosis are not eligible.
  • Grade 2 or greater peripheral neuropathy.
  • Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
  • Patients who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and patients whose circumstances do not permit completion of the study or the required follow-up.
  • Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
  • Patients requiring concurrent treatment with corticosteroids unless chronic treatment (> 6 months) at low doses (< 20 mg/day of methylprednisolone or equivalent).
  • Patients receiving an investigational drug within 3 weeks of registration.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical Affairs Study Director, sanofi-aventis
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Study Director: Yasir Nagarwala, MD Sanofi
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP