Clinical trial NCT00059722: This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.
Official title: A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC
locally advanced or metastatic
second-line
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-05-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
* Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion Criteria:

* Subjects who have received second-line or subsequent chemotherapy
* Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)

Primary outcomes:
measure: Primary Outcomes:
measure: Part A
measure: i. Time to progression
measure: ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
measure: Part B
Secondary outcomes:
measure: Secondary Outcomes:
measure: Part A
measure: i. Objective response
measure: ii. Disease control at 8 weeks
measure: iii. Time to death
measure: iv. WHO performance status
measure: v. QOL and LCS from the FACT-L questionnaire
measure: Part B
measure: i. Objective response in subjects following treatment with the alternate study treatment
measure: ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
measure: iii. WHO performance status in subjects following treatment with the alternate study treatment
measure: iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment
Other outcomes:
Locations:
city: Pine Bluff
country: United States
facility: Research Site
state: Arkansas
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Orange Park
country: United States
facility: Research Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: St. Loius
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Bismarck
country: United States
facility: Research Site
state: North Dakota
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Brussels (Jette)
country: Belgium
facility: Research Site
city: Brussels (Woluwé-St-Lambert)
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Essen
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Research Site
state: Rheinland-Pfalz
city: Ryhope
country: Germany
facility: Research Site
state: Sunderland
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Parktown
country: South Africa
facility: Research Site
city: Port Elizabeth
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
state: Middlesex
city: Cardiff
country: United Kingdom
facility: Research Site
state: South Glamorgan
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: