- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00819728
Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer
January 10, 2011 updated by: Sanofi
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis US
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Taxotere/Irinotecan
|
35mg/m2 IV each week for 4 weeks
Other Names:
50mg/m2 IV each week for 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yasir Nagarwala, MD, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2000
Study Completion (Actual)
January 1, 2003
Study Registration Dates
First Submitted
January 7, 2009
First Submitted That Met QC Criteria
January 8, 2009
First Posted (Estimate)
January 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 11, 2011
Last Update Submitted That Met QC Criteria
January 10, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Docetaxel
- Irinotecan
Other Study ID Numbers
- RP56976_US1_203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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