- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00424853
ADVANCED Phase II Trial of Weekly vs 3 Weekly Docetaxel and Cisplatin Followed by Gemcitabine in Non-small-cell Lung Cancer (NSCLC)
December 4, 2009 updated by: Sanofi
Randomized Phase II Trial of Two Sequential Schedules of Docetaxel and Cisplatin Followed by Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer.
This is a multicenter, open-label, randomized phase II trial whose aim is to assess the antitumor activity of two sequential schedules of docetaxel and cisplatin followed by gemcitabine.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
88
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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Milan, Italy
- Sanofi-Aventis Administrative Office
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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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of NSCLC; Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
- Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System;
- Patients must have at least one measurable lesion according to RECIST criteria.
- Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented;
- WHO Performance Status 0 or 1 ;
- Weight loss < 5% within the last 3 months;
Laboratory requirements at entry
- Blood cell counts: Absolute neutrophils > 2.0 . 10^9/L; Platelets > 100 . 10^9/L; Hemoglobin > 10 g/dl
- Renal function: Serum creatinine < 1 upper normal limits (UNL). In case of limit value of serum creatinine, the creatinine clearance should be > 60 mL/min
- Hepatic functions: Serum bilirubin < 1 x UNL; ASAT and ALAT < 2.5 x UNL; Alkaline phosphatase < 5 x UNL (unless accompanied by extensive bone metastases)
Exclusion Criteria:
- Prior systemic chemotherapy or immunotherapy ; prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment;
- Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy (to < 25% of the bone marrow) is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiotherapy and the patient must have all side effects recovered.
- Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
- Patients with evaluable, not measurable disease only (non target lesions);
- Patients with symptomatic brain metastases or with leptomeningeal disease;
- History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years;
- History of hypersensitivity reaction to polysorbate 80;
- Pregnant or lactating women (women of childbearing potential must use adequate contraception);
- Current peripheral neuropathy NCI grade > 2;
- Significant neurological or psychiatric disorders ;
- Participation in clinical trials with other experimental agents within 30 days of study entry;
Other serious concomitant illness of medical conditions:
- Uncontrolled cardiovascular disease;
- History of significant neurologic or psychiatric disorders including demential or seizures;
- Active infection requiring iv antibiotics;
- Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy;
- Any other condition which in the judgement of the investigator would place the subject at undue risk or interfere with the study.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
docetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles
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Experimental: B
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docetaxel 25 mg/m2 day 1,8,15 + cisplatin 25 mg/m2 days1,8,15 repeated every 28 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rate assessed by RECIST criteria.
Time Frame: before, during and at the end of treatment
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before, during and at the end of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to progression
Time Frame: from the date of randomization to the date of first documented tumor progression or relapse
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from the date of randomization to the date of first documented tumor progression or relapse
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time to treatment failure
Time Frame: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administraztion of other antitumor treatment, or death for any cause
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from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administraztion of other antitumor treatment, or death for any cause
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overall survival
Time Frame: time interval from the date of randomisation to the date of death
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time interval from the date of randomisation to the date of death
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Georges Paizis, 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
May 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
January 19, 2007
First Submitted That Met QC Criteria
January 19, 2007
First Posted (Estimate)
January 22, 2007
Study Record Updates
Last Update Posted (Estimate)
December 7, 2009
Last Update Submitted That Met QC Criteria
December 4, 2009
Last Verified
December 1, 2009
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
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gemcitabine
- Docetaxel
- Cisplatin
Other Study ID Numbers
- XRP6976B_2506
- EudraCT # : 2004-001044-72
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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