Three Combinations Of Docetaxel And Irinotecan For Recurrent Or Metastatic Non Small Cell Lung Cancer

Pfizer138 enrolled

Overview

A multicenter randomized phase II study evaluating the activity and tolerability of three different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy for recurrent or metastatic non small cell lung cancer (NSCLC)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

IrinotecanDRUG

DocetaxelDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically proven NSCLC * Recurrent or metastatic NCSLC Exclusion Criteria: * Prior malignancies; except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer adequately treated an with non evidence of disease for at least 5 years * History or presence of brain or meningeal metastases

Locations (15)

Pfizer Investigational Site

Alzano Lombardo, BG, Italy

Pfizer Investigational Site

Gravedona, CO, Italy

Pfizer Investigational Site

Crema, CR, Italy

Outcomes

Primary Outcomes

Evaluate the activity and tolerability of the association of irinotecan and docetaxel according to three different schedules as second line treatment for recurrent or metastatic NSCLC.

Secondary Outcomes

Evaluate, in each arm, the time to progression, the duration of response and the survival

Data from ClinicalTrials.gov

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