Clinical trial NCT00071188: ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Official title: A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small-Cell Lung Carcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-10-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* 18 years or older
* Histologically or cytologically confirmed locally advanced or metastatic NSCLC
* No prior chemotherapy/biological therapy/radiation therapy
* One or more measurable lesions
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Brain metastases or spinal cord compression
* Currently active skin disease
* History of significant hemoptysis
* Abnormal blood chemistry
* Cardiac abnormalities
* Recent significant cardiac event
* Coexisting malignancies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Helsinki
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Panorama
country: South Africa
facility: Research Site
city: Parkland
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Chiang mai
country: Thailand
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: