Clinical trial NCT00047840: This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.
Official title: A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-10-24
Enrollment: 129
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 this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
* Failure of first-line platinum-based chemotherapy

Exclusion Criteria:

* Mixed small cell or non-small-cell histology
* Bronchoalveolar carcinoma
* Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
* Prior treatment with docetaxel

Primary outcomes:
measure: Outcome Progression free survival
Secondary outcomes:
measure: Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
measure: Objective response rate and duration of response
measure: QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
measure: WHO performance status
measure: Time to death
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Pittsfield
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Billings
country: United States
facility: Research Site
state: Montana
city: Great Neck
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Coos Bay
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Brno
country: Czech Republic
facility: Research Site
city: Chomutov
country: Czech Republic
facility: Research Site
city: Hradec
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: