GILT Docetaxel - Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174629
First received: September 9, 2005
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

Primary Objective:

  • To compare response rate between genotypic groups and control group.

Secondary Objective:

  • To determine the safety, time to treatment failure and survival in control and genotypic arms.

Condition Intervention Phase
Lung Neoplasms
Drug: Docetaxel/DDP
Drug: docetaxel/gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Cooperative, Randomized, Multicenter Phase III Study on the Use of Cisplatin Resistant Genotype (ERCC1 Over-Expression) in Tumor RNA to Customize Chemotherapy in Stage IV-IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.

Secondary Outcome Measures:
  • Time to treatment failure and survival [ Time Frame: calculated from the registration date until progression or death, respectively ] [ Designated as safety issue: No ]
  • Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria. [ Time Frame: before each cycle ] [ Designated as safety issue: No ]
  • Adverse events not reported in NCIC-CTG Expanded Common Toxicity Criteria will be graded as mild, moderate, severe, and life threatening. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 449
Study Start Date: June 2001
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: docetaxel/gemcitabine
Active Comparator: 2 Drug: Docetaxel/DDP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must be/have:

  • histologically confirmed non-small cell lung cancer (squamous cell carcinoma, large cells or adenocarcinoma; it is recommended to provide the full paraffin-embedded block or at least 5 5 sections obtained from the primary tumor, recurrence or metastasis, not stained, fixed in formalin/embedded in paraffin, mounted on slides (10 micron sections), as well as two serum samples in two 10-ml tubes and two blood samples (see appendix X);
  • unresectable metastatic (stage IV or IIIB malignant pleural effusion) NSCLC;
  • WHO performance status < 2;
  • Adequate bone marrow, hepatic and renal functions, assessed during the previous 14 days, that should be shown by the following characteristics:

    • hemoglobin > or = 10g/dl and no blood cell transfusion within the previous 2 weeks;
    • absolute neutrophil count > 2.0 10^9 cells/l;
    • platelet count > or = 100.10^9 cells/l;
    • no evidence of myelodysplastic syndrome or abnormal bone marrow reserve;
    • creatinine < or = 1.5 x UNL or creatinine clearance > or = 60 ml/min (real or calculated);
    • total bilirubin < or = UNL;
    • ASAT (SGOT) and/or ALAT (SGPT) < or = 1.5 x UNL;
    • alkaline phosphatases < or = 5 x UNL;
    • serum calcium < or = 1.1 x UNL;
  • at least one measurable lesion;
  • previous surgery intervention (more than 30 days before inclusion in the study) is allowed but metastatic disease must be demonstrated;
  • previous radiotherapy is allowed if:

    • less or equal to 10% of bone marrow has been irradiated
    • end of radiotherapy 21 days or more prior to inclusion in the study;
    • patient has fully recovered from all toxic effects;
    • at least one of the measurable target lesions for evaluation of tumor response has not been irradiated;
  • the patient must be accessible for treatment and follow-up. The patient entered into this trial must be treated and followed up at the participating center;
  • life expectancy > or = 12 weeks;
  • The initial diagnostic procedures should be performed during the 4 weeks prior to the randomization.

Exclusion Criteria:

  • pregnant or lactating women (women of childbearing potential must use adequate contraception);
  • prior systemic chemotherapy or immunotherapy for NSCLC, even as neoadjuvant or adjuvant therapy;
  • prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 5 years;
  • history or clinical symptomatic brain or leptomeningeal metastases;
  • current peripheral neuropathy and neurohearing > or = NCIC-CTG grade 2 except if due to trauma;
  • other serious illness or medical condition, including:

    • congestive heart disease; prior myocardial infarction within 6 months;
    • history of significant neurologic or psychiatric disorders that would inhibit their understanding and giving of informed consent;
    • infection requiring I.V. antibiotics and tuberculosis under treatment ongoing at study entry;
    • untreated superior vena cava syndrome;
    • active peptic ulcer; unstable diabetes mellitus or other contraindication to high dose corticotherapy such as herpes, herpes zoster, cirrhosis;
  • hypercalcemia requiring therapy;
  • preexisting ascitis and/or clinical significant pericardial effusion;
  • patients whose lesion(s) are assessable only by radionuclide scan;
  • history of allergy to drugs containing the excipient TWEEN 80®;
  • concurrent treatment with other investigational drugs;
  • participation in a clinical trial of one or more investigational agents (i.e. antibiotic) or devices within 30 days of study entry.

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: NCT00174629

Locations
Germany
Sanofi-Aventis
Berlin, Germany
Spain
Sanofi-Aventis
Barcelona, Spain
Switzerland
Sanofi-Aventis
Genève, Switzerland
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jean-Philippe Aussel Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174629     History of Changes
Other Study ID Numbers: TAX_ES1_302
Study First Received: September 9, 2005
Last Updated: December 4, 2009
Health Authority: Spain: Spanish Agency of Medicines

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
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014