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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00424853
First received: January 19, 2007
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Docetaxel and cisplatin followed by gemcitabine
Drug: docetaxel and cisplatin followed by gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • overall response rate assessed by RECIST criteria. [ Time Frame: before, during and at the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: from the date of randomization to the date of first documented tumor progression or relapse ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: time interval from the date of randomisation to the date of death ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: May 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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 ClinicalTrials.gov identifier: NCT00424853

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

No publications provided

Responsible Party: Medical Affairs Medical Director, Sanofi-aventis administrative office
ClinicalTrials.gov Identifier: NCT00424853     History of Changes
Other Study ID Numbers: XRP6976B_2506, EudraCT # : 2004-001044-72
Study First Received: January 19, 2007
Last Updated: December 4, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators

ClinicalTrials.gov processed this record on August 28, 2014