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NCT Number: NCT00191490

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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, 50019, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

docetaxel

Drug

Cisplatin

Drug

Primary outcomes

  1. 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

  2. cisplatin /gemcitabine

Secondary outcomes

  1. To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.

  2. To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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