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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191490

Enrollment

162

Registered

2005-09-19

Start date

2002-07-31

Completion date

2005-05-31

Last updated

2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief summary

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.

Interventions

DRUGGemcitabine

DRUGdocetaxel

DRUGcisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026