Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00254904
• Other study ID #: A8501002
• Status: Terminated
• Phase: Phase 3
• First received: November 15, 2005
• Last updated: March 10, 2015
• Start date: November 2005
• Est. completion date: June 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 gemcitabine/cisplatin 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 gemcitabine/cisplatin alone.

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 (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 839
• Est. completion date: June 2008
• Est. primary completion date: June 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 Group 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:
• Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
• Gemcitabine
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
• PF-3512676
PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
• Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
• Gemcitabine + Cisplatin
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Innsbruck
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Charleroi
Belgium	Pfizer Investigational Site	Hasselt
Belgium	Pfizer Investigational Site	Jette
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Liege
Brazil	Pfizer Investigational Site	Jau	SP
Brazil	Pfizer Investigational Site	Jaú	SP
Brazil	Pfizer Investigational Site	Jaú	SP
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Canada	Pfizer Investigational Site	Greenfield Park	Quebec
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	Levis	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Windsor	Ontario
Canada	Pfizer Investigational Site	Windsor	Ontario
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Dalian	Liaoning
China	Pfizer Investigational Site	Guangzhou	Guangdong
China	Pfizer Investigational Site	Nanjing	Jiangsu
Czech Republic	Pfizer Investigational Site	Olomouc
Czech Republic	Pfizer Investigational Site	Praha 5	CZ
Czech Republic	Pfizer Investigational Site	Praha 8
Germany	Pfizer Investigational Site	Bielefeld
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Loewenstein
Germany	Pfizer Investigational Site	Mannheim
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Tuebingen
Hong Kong	Pfizer Investigational Site	Kowloon
Hong Kong	Pfizer Investigational Site	Shatin
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Deszk
Hungary	Pfizer Investigational Site	Gyula
Hungary	Pfizer Investigational Site	Pecs
Hungary	Pfizer Investigational Site	Zalaegerszeg	Külsokórház-Pózva
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Kochi	Kerala
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	New Delhi
India	Pfizer Investigational Site	Pune	Maharashtra
Israel	Pfizer Investigational Site	Beer-Sheva
Israel	Pfizer Investigational Site	Kfar Saba
Italy	Pfizer Investigational Site	Forli'
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	S.Andrea delle Fratte (PG)
Korea, Republic of	Pfizer Investigational Site	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Netherlands	Pfizer Investigational Site	's-Hertogenbosch
Netherlands	Pfizer Investigational Site	Amsterdam	NH
Netherlands	Pfizer Investigational Site	Harderwijk
Netherlands	Pfizer Investigational Site	Nijmegen
Netherlands	Pfizer Investigational Site	Zaandam	NH
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Otwock
Poland	Pfizer Investigational Site	Szczecin-Zdunowo
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wodzislaw Sl.
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Singapore	Pfizer Investigational Site	Singapore
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Kvetnica pri Poprade
Slovakia	Pfizer Investigational Site	Nitra-Zobor
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Port Elizabeth
South Africa	Pfizer Investigational Site	Port Elizabeth	Eastern Cape
Spain	Pfizer Investigational Site	Alicante
Spain	Pfizer Investigational Site	Baracaldo	Vizcaya
Spain	Pfizer Investigational Site	Castellon
Spain	Pfizer Investigational Site	Gerona
Spain	Pfizer Investigational Site	Hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Jaen
Spain	Pfizer Investigational Site	Santander	Cantabria
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Bornova / Izmir
Turkey	Pfizer Investigational Site	Istanbul / Ceraahpasa
United Kingdom	Pfizer Investigational Site	Belfast
United Kingdom	Pfizer Investigational Site	Bristol	Avon
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	Edinburgh
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Leicester
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Southampton	Hampshire
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United Kingdom	Pfizer Investigational Site	Wolverhampton
United States	Pfizer Investigational Site	Bakersfield	California
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	St. Joseph	Michigan
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Canada,  China,  Czech Republic,  Germany,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Singapore,  Slovakia,  South Africa,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		656 Events	No
Secondary	Patient Reported Outcomes		End of treatment	No
Secondary	Overall Safety Profile		28 days post PF03512676 dosing	Yes
Secondary	Progression Free Survival		Time of primary endpoint	No
Secondary	Time to Tumor Progression		Time of progressive disease	No
Secondary	Overall Objective Response		End of treatment	No
Secondary	Duration of Response		Time of progressive disease	No

External Links

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