Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00254891
• Other study ID #: A8501001
• Status: Terminated
• Phase: Phase 3
• First received: November 15, 2005
• Last updated: March 10, 2015
• Start date: November 2005
• Est. completion date: July 2008

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

Description:

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 828
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV

• No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs

• Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

• Small cell or carcinoid lung cancer

• Known Central Nervous System (CNS) metastasis

• Pre-existing auto-immune or antibody mediated diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• PF-3512676 + Paclitaxel + Carboplatin
PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
• Paclitaxel + Carboplatin
Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Albury	New South Wales
Australia	Pfizer Investigational Site	Bedford Park	South Australia
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	East Melbourne	Victoria
Australia	Pfizer Investigational Site	East Ringwood	Victoria
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	Pimlico	Queensland
Australia	Pfizer Investigational Site	Randwick	New South Wales
Australia	Pfizer Investigational Site	Toorak Gardens	South Australia
Australia	Pfizer Investigational Site	Townsville	Queensland
Australia	Pfizer Investigational Site	Wodonga	Victoria
Australia	Pfizer Investigational Site	Woolloongabba	Queensland
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Liège
Canada	Pfizer Investigational Site	Moncton	New Brunswick
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Rimouski	Quebec
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Dalian, Xigang District	Liaoning
China	Pfizer Investigational Site	Shanghai
Cyprus	Pfizer Investigational Site	Nicosia
Czech Republic	Pfizer Investigational Site	Nova Ves Pod Plesi
Czech Republic	Pfizer Investigational Site	Ostrava-Poruba
Czech Republic	Pfizer Investigational Site	Usti nad Labem
France	Pfizer Investigational Site	Angers cedex
France	Pfizer Investigational Site	Caen cedex
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Limoges
France	Pfizer Investigational Site	Nantes Cedex 2
France	Pfizer Investigational Site	Paris Cedex 13
France	Pfizer Investigational Site	St Herblain Cedex
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Toulouse cedex 9
France	Pfizer Investigational Site	Vandoeuvre Les Nancy
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bielefeld
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Muenchen
Greece	Pfizer Investigational Site	Athens	Attica
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Heraklion	Crete
Greece	Pfizer Investigational Site	Rio, Patras
Greece	Pfizer Investigational Site	Thessaloniki	Macedonia
Hong Kong	Pfizer Investigational Site	Pokfulam
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Debrecen
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Chandigarh	Punjab
India	Pfizer Investigational Site	Jaipur	Rajasthan
India	Pfizer Investigational Site	Kochi	Kerala
India	Pfizer Investigational Site	Pune	Maharashtra
Israel	Pfizer Investigational Site	Zerifin
Italy	Pfizer Investigational Site	Lido di Camaiore (LU)
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Pavia
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Puebla
Netherlands	Pfizer Investigational Site	Amstelveen
Netherlands	Pfizer Investigational Site	Den Haag
Netherlands	Pfizer Investigational Site	Groningen	GR
Netherlands	Pfizer Investigational Site	Tiel	GLD
Poland	Pfizer Investigational Site	Otwock
Poland	Pfizer Investigational Site	Wodzislaw Sl.
Portugal	Pfizer Investigational Site	Faro
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Vila Nova de Gaia
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Parktown	Gauteng
Spain	Pfizer Investigational Site	Alcorcon	Madrid
Spain	Pfizer Investigational Site	Badalona	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Pamplona	Navarra
Spain	Pfizer Investigational Site	Santa Cruz de Tenerife
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Uppsala
Switzerland	Pfizer Investigational Site	Lausanne
Taiwan	Pfizer Investigational Site	Taipei
United Kingdom	Pfizer Investigational Site	Exeter	Devon
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Portsmouth
United Kingdom	Pfizer Investigational Site	Sheffield
United Kingdom	Pfizer Investigational Site	Surrey GU2 5XX
United Kingdom	Pfizer Investigational Site	Swansea
United Kingdom	Pfizer Investigational Site	Truro	Cornwall
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Allegan	Michigan
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Asheville	North Carolina
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Biddeford	Maine
United States	Pfizer Investigational Site	Bountiful	Utah
United States	Pfizer Investigational Site	Brevard	North Carolina
United States	Pfizer Investigational Site	Brunswick	Maine
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Burlington	Vermont
United States	Pfizer Investigational Site	Canton	Ohio
United States	Pfizer Investigational Site	Cedar Rapids	Iowa
United States	Pfizer Investigational Site	Chattanooga	Tennessee
United States	Pfizer Investigational Site	Chula Vista	California
United States	Pfizer Investigational Site	Columbus	Mississippi
United States	Pfizer Investigational Site	Corinth	Mississippi
United States	Pfizer Investigational Site	Covington	Louisiana
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Dover	Ohio
United States	Pfizer Investigational Site	Dubuque	Iowa
United States	Pfizer Investigational Site	Everett	Washington
United States	Pfizer Investigational Site	Fayetteville	Georgia
United States	Pfizer Investigational Site	Great Neck	New York
United States	Pfizer Investigational Site	Gretna	Louisiana
United States	Pfizer Investigational Site	Hot Springs	Arkansas
United States	Pfizer Investigational Site	Jefferson	Indiana
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Kennewick	Washington
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	Lafayette	Louisiana
United States	Pfizer Investigational Site	Langhorne	Pennsylvania
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Layton	Utah
United States	Pfizer Investigational Site	Lexington	North Carolina
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Little Rock	Alaska
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Macon	Georgia
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Marrero	Louisiana
United States	Pfizer Investigational Site	Marrero	Louisiana
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Murray	Utah
United States	Pfizer Investigational Site	New Albany	Indiana
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Palm Springs	California
United States	Pfizer Investigational Site	Papillion	Nebraska
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Provo	Utah
United States	Pfizer Investigational Site	Richardson	Texas
United States	Pfizer Investigational Site	Richland	Washington
United States	Pfizer Investigational Site	Rockford	Illinois
United States	Pfizer Investigational Site	Ruidoso	New Mexico
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Scarborough	Maine
United States	Pfizer Investigational Site	Shelbyville	Kentucky
United States	Pfizer Investigational Site	St. Joseph	Michigan
United States	Pfizer Investigational Site	Trophy Club	Texas
United States	Pfizer Investigational Site	Tucker	Georgia
United States	Pfizer Investigational Site	Tupelo	Mississippi
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Worcester	Massachusetts
United States	Pfizer Investigational Site	WVC	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Cyprus,  Czech Republic,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		656 Events	No
Secondary	Overall Objective Response		End of Treatment	No
Secondary	Time to Tumor Progression		Time of progressive disease	No
Secondary	Progression Free Survival		Time of primary endpoint	No
Secondary	Duration of Response		Time of progressive disease	No
Secondary	Patient Reported Outcomes		End of Treatment	No
Secondary	Overall Safety Profile		28 days post PF-3512676 dosing	Yes

External Links

•   To obtain contact information for a study center near you, click here.