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ADVANCED Phase II Trial of Weekly vs 3 Weekly Docetaxel and Cisplatin Followed by Gemcitabine in Non-small-cell Lung Cancer (NSCLC)

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: NCT00424853
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : December 7, 2009
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Docetaxel and cisplatin followed by gemcitabine Drug: docetaxel and cisplatin followed by gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Two Sequential Schedules of Docetaxel and Cisplatin Followed by Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer.
Study Start Date : May 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: Docetaxel and cisplatin followed by gemcitabine
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

Experimental: B Drug: docetaxel and cisplatin followed by gemcitabine
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.

Primary Outcome Measures :
  1. overall response rate assessed by RECIST criteria. [ Time Frame: before, during and at the end of treatment ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: from the date of randomization to the date of first documented tumor progression or relapse ]
  2. 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 ]
  3. overall survival [ Time Frame: time interval from the date of randomisation to the date of death ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    1. Uncontrolled cardiovascular disease;
    2. History of significant neurologic or psychiatric disorders including demential or seizures;
    3. Active infection requiring iv antibiotics;
    4. Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy;
    5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424853

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Sanofi-Aventis Administrative Office
Milan, Italy
Sponsors and Collaborators
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Study Director: Georges Paizis, MD Sanofi

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Responsible Party: Medical Affairs Medical Director, Sanofi-aventis administrative office Identifier: NCT00424853    
Other Study ID Numbers: XRP6976B_2506
EudraCT # : 2004-001044-72
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators