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

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 (NSCLS)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139711

Enrollment

138

Registered

2005-08-31

Start date

2003-03-31

Completion date

2006-06-30

Last updated

2008-04-01

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

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)

Interventions

DRUGIrinotecan

DRUGDocetaxel

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 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Evaluate, in each arm, the time to progression, the duration of response and the survival	—

Countries

Italy

Outcome results

None listed

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