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.
Aventis Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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

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

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
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: NCT00191490

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
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

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, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tubulin Modulators

ClinicalTrials.gov processed this record on May 24, 2016