Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— NSCLC  

Official title:

Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00673049
• Other study ID #: A4021018
• Status: Terminated
• Phase: Phase 3
• First received: May 5, 2008
• Last updated: July 22, 2013
• Start date: May 2008
• Est. completion date: April 2012

Study information

• Verified date: July 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Description:

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 583
• Est. completion date: April 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

• Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.

• Prior Erlotinib therapy.

• Prior anti IGF IR based investigational therapy.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Adenosquamous Cell
• Carcinoma, Large Cell
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell

Intervention

Drug:
• CP 751,871 (Figitumumab)
CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
• Erlotinib
Erlotinib (one tablet of 150 mg/day PO).
• Erlotinib
Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brasschaat
Belgium	Pfizer Investigational Site	Mons
Brazil	Pfizer Investigational Site	Higienopolis	Sao Paulo/ Brazil
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Santo André	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Varna
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Chile	Pfizer Investigational Site	Independencia	Santiago, RM
Czech Republic	Pfizer Investigational Site	Kutna Hora
Czech Republic	Pfizer Investigational Site	Nova Ves pod Plesi
Czech Republic	Pfizer Investigational Site	Praha 8
Czech Republic	Pfizer Investigational Site	Tabor
France	Pfizer Investigational Site	BREST Cedex
France	Pfizer Investigational Site	La Tronche
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Marseille Cedex 09
France	Pfizer Investigational Site	Marseille Cedex 20
France	Pfizer Investigational Site	Rennes	Cedex 9
France	Pfizer Investigational Site	Saint Pierre la Réunion Cedex
France	Pfizer Investigational Site	St Priest En Jarez Cedex
France	Pfizer Investigational Site	Villejuif
Greece	Pfizer Investigational Site	Heraklion	Crete
Greece	Pfizer Investigational Site	Larisa
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Matrahaza
Hungary	Pfizer Investigational Site	Szekesfehervar
Indonesia	Pfizer Investigational Site	Jakarta	DKI Jakarta
Indonesia	Pfizer Investigational Site	Surabaya	East Java
Ireland	Pfizer Investigational Site	Cork
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin 24
Italy	Pfizer Investigational Site	Avellino
Italy	Pfizer Investigational Site	Aviano (PN)
Italy	Pfizer Investigational Site	Cattolica (RN)
Italy	Pfizer Investigational Site	Modena
Italy	Pfizer Investigational Site	Orbassano (TO)
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Rimini
Italy	Pfizer Investigational Site	Roma
Korea, Republic of	Pfizer Investigational Site	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Latvia	Pfizer Investigational Site	Riga
Latvia	Pfizer Investigational Site	Riga
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Olsztyn
Poland	Pfizer Investigational Site	Olsztyn
Poland	Pfizer Investigational Site	Rybnik
Poland	Pfizer Investigational Site	Wodzislaw Sl.
Puerto Rico	Pfizer Investigational Site	Ponce
Romania	Pfizer Investigational Site	Cluj-Napoca	Cluj
Romania	Pfizer Investigational Site	Cluj-Napoca
Romania	Pfizer Investigational Site	Iasi
Russian Federation	Pfizer Investigational Site	Krasnodar
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Sochi
Russian Federation	Pfizer Investigational Site	St-Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Sremska Kamenica
Slovenia	Pfizer Investigational Site	Ljubljana
South Africa	Pfizer Investigational Site	Bloemfontein
South Africa	Pfizer Investigational Site	Cape Town
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Elche	Alicante
Spain	Pfizer Investigational Site	Girona
Spain	Pfizer Investigational Site	L'hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Manresa	Barcelona
Spain	Pfizer Investigational Site	Oviedo	Asturias
Spain	Pfizer Investigational Site	Sabadell	Barcelona
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Sevilla
Switzerland	Pfizer Investigational Site	Basel
Switzerland	Pfizer Investigational Site	Basel
Switzerland	Pfizer Investigational Site	CH-4101 Bruderholz
Switzerland	Pfizer Investigational Site	Chur
Switzerland	Pfizer Investigational Site	Liestal
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taoyuan County
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Sumy
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Alpharetta	Georgia
United States	Pfizer Investigational Site	Amherst	New York
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	Beech Grove	Indiana
United States	Pfizer Investigational Site	Bethesda	Maryland
United States	Pfizer Investigational Site	Billings	Montana
United States	Pfizer Investigational Site	Bloomington	Illinois
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Butte	Montana
United States	Pfizer Investigational Site	Cedar Rapids	Iowa
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Cody	Wyoming
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Conyers	Georgia
United States	Pfizer Investigational Site	Cumming	Georgia
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Duluth	Georgia
United States	Pfizer Investigational Site	Fort Smith	Arkansas
United States	Pfizer Investigational Site	Germantown	Tennessee
United States	Pfizer Investigational Site	Gloucester	Virginia
United States	Pfizer Investigational Site	Glouster	Virginia
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Hot Springs	Arkansas
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Lafayette	Colorado
United States	Pfizer Investigational Site	Lake City	Florida
United States	Pfizer Investigational Site	Lake City	Florida
United States	Pfizer Investigational Site	Lake Spivey	Georgia
United States	Pfizer Investigational Site	Lake Success	New York
United States	Pfizer Investigational Site	Lakeport	California
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Manchester	New Hampshire
United States	Pfizer Investigational Site	Manhasset	New York
United States	Pfizer Investigational Site	New Albany	Mississippi
United States	Pfizer Investigational Site	New Hyde Park	New York
United States	Pfizer Investigational Site	Newport News	Virginia
United States	Pfizer Investigational Site	Norman	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Peoria	Illinois
United States	Pfizer Investigational Site	Petaluma	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Santa Rosa	California
United States	Pfizer Investigational Site	Snellville	Georgia
United States	Pfizer Investigational Site	Thousand Oaks	California
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Waterloo	Iowa
United States	Pfizer Investigational Site	Wenatchee	Washington
United States	Pfizer Investigational Site	Westlake Valley	California
United States	Pfizer Investigational Site	Wheeling	West Virginia
United States	Pfizer Investigational Site	Williamsburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czech Republic,  France,  Greece,  Hungary,  Indonesia,  Ireland,  Italy,  Korea, Republic of,  Latvia,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovenia,  South Africa,  Spain,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.	Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months	No
Secondary	Progression Free Survival (PFS)	Time from randomization to date of first documentation of progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, who had a baseline and at least 1 on-study disease assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions.	Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months	No
Secondary	Percentage of Participants With Objective Response	Percentage of participants with objective response (OR) based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR are defined as complete disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for Figitumumab		Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab		Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group	No
Secondary	Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)	ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.	Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group	No
Secondary	Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)		Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)	No
Secondary	Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)	EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose)	No
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)	EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.	Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)	No
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)	QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.	Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)	No

External Links

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