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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Chair

Investigator Affiliation:

Eli Lilly and Company

Authority:

Italy: Ministry of Health

Study ID:

6549

NCT ID:

NCT00191490

Start Date:

July 2002

Completion Date:

May 2005

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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