Taxotere Combinations as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00425191
First received: January 19, 2007
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

To assess the antitumour activity (response rate) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each treatment arms.· To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.· To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Docetaxel and Gemcitabine
Drug: Gemcitabine cisplatin followed by docetaxel
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: A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Performed after 3 cycles and at the end of treatment (6 cycles). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression. [ Time Frame: Time from treatment to the documented profession of disease. ] [ Designated as safety issue: Yes ]

Enrollment: 165
Study Start Date: July 2002
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Docetaxel and Gemcitabine
Docetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8
Experimental: 2 Drug: Docetaxel and Gemcitabine
Docetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15.
Experimental: 3 Drug: Gemcitabine cisplatin followed by docetaxel
Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2

  Eligibility

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

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of NSCLC istologic 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;
  • Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented whenever possible;
  • Weight loss < = 5% within the last 3 months;
  • Laboratory requirements at entry :

    • Blood cell counts: Absolute neutrophils > 2.0 x 109/LPlatelets > 100 x 109/LHemoglobin > 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 UNLASAT and ALAT < 2.5 x UNLAlkaline phosphatase < 5 x UNL (unless accompanied by extensive bone metastases);

Exclusion criteria:

  • Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments;
  • Prior radiotherapy for NSCLC;
  • Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
  • Patients with not measurable disease only;
  • Patients with symptomatic brain metastases or with leptomeningeal disease. However; patients with symptomatic brain metastases who become asymptomatic under corticosteriods treatment can enter the study;
  • 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);
  • Concurrent treatment with other experimental drugs;
  • Current peripheral neuropathy NCI grade > = 2;
  • Significant neurological or psychiatric disorders;
  • Hepatic functions abnormalities;
  • Participation in clinical trials with other experimental agents within 30 days of study entry;
  • Other serious concomitant illness of medical conditions;
  • 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, undoes risk or interferes with the study.
  • Treatment with biphosphonates.
  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: NCT00425191

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00425191     History of Changes
Other Study ID Numbers: XRP6976B_2501
Study First Received: January 19, 2007
Last Updated: December 4, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
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
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 29, 2014