A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191490
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
  Purpose

Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the evaluation of the pathological complete response after 8 instillation of gemcitabine. 46 patients are requested.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Gemcitabine
Drug: docetaxel
Drug: cisplatin
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 (RP56976, TAXOTERE *) 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 Eli Lilly and Company:

Primary Outcome Measures:
  • To assess the antitumour activity as measured by 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 162
Study Start Date: July 2002
Estimated Study Completion Date: May 2005
  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
  • 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
  • WHO Performance Status 0 or 1
  • Adequate Organ Function

Exclusion criteria:

  • Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments
  • Prior radiotherapy for NSCLC
  • Patients with symptomatic brain metastases or with leptomeningeal disease. However, patients with symptomatic brain metastases who become asymptomatic under corticosteroids treatment can enter the study
  • Current peripheral neuropathy NCI grade 2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191490

Locations
Italy
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 am to 5:00 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician
Sesto Fiorentino, Florence, Italy, 50019
Sponsors and Collaborators
Eli Lilly and Company
Aventis Pharmaceuticals
Investigators
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00191490     History of Changes
Other Study ID Numbers: 6549, B9E-IT-JHSC
Study First Received: September 12, 2005
Last Updated: January 24, 2007
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
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 22, 2014