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

July 22, 2013 updated by: Pfizer

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

583

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brasschaat, Belgium, 2930
        • Pfizer Investigational Site
      • Mons, Belgium, 7000
        • Pfizer Investigational Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20231 -050
        • Pfizer Investigational Site
      • Rio de Janeiro, RJ, Brazil, 20230 -130
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Pfizer Investigational Site
    • SP
      • Santo André, SP, Brazil, 09060-650
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01224-010
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01221-020
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 01219-000
        • Pfizer Investigational Site
    • Sao Paulo/ Brazil
      • Higienopolis, Sao Paulo/ Brazil, Brazil, 01224-010
        • Pfizer Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1527
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1756
        • Pfizer Investigational Site
      • Varna, Bulgaria, 9000
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
  • Chile
    • Santiago, RM
      • Independencia, Santiago, RM, Chile, 8380455
        • Pfizer Investigational Site
  • Czech Republic
      • Kutna Hora, Czech Republic, 284 01
        • Pfizer Investigational Site
      • Nova Ves pod Plesi, Czech Republic, 26204
        • Pfizer Investigational Site
      • Praha 8, Czech Republic, 180 81
        • Pfizer Investigational Site
      • Tabor, Czech Republic, 390 03
        • Pfizer Investigational Site
  • France
      • BREST Cedex, France, 29609
        • Pfizer Investigational Site
      • La Tronche, France, 38700
        • Pfizer Investigational Site
      • Lille, France, 59020 Cedex
        • Pfizer Investigational Site
      • Marseille Cedex 09, France, 13009
        • Pfizer Investigational Site
      • Marseille Cedex 20, France, 13915
        • Pfizer Investigational Site
      • Saint Pierre la Réunion Cedex, France, 97448
        • Pfizer Investigational Site
      • St Priest En Jarez Cedex, France, 42277
        • Pfizer Investigational Site
      • Villejuif, France, 94805
        • Pfizer Investigational Site
    • Cedex 9
      • Rennes, Cedex 9, France, 35033
        • Pfizer Investigational Site
  • Greece
      • Larisa, Greece, 41110
        • Pfizer Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 71110
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1525
        • Pfizer Investigational Site
      • Matrahaza, Hungary, H-3233
        • Pfizer Investigational Site
      • Szekesfehervar, Hungary, 8000
        • Pfizer Investigational Site
  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 13230
        • Pfizer Investigational Site
    • East Java
      • Surabaya, East Java, Indonesia, 60286
        • Pfizer Investigational Site
  • Ireland
      • Cork, Ireland
        • Pfizer Investigational Site
      • Dublin, Ireland, 8
        • Pfizer Investigational Site
      • Dublin 24, Ireland
        • Pfizer Investigational Site
  • Italy
      • Avellino, Italy, 83100
        • Pfizer Investigational Site
      • Aviano (PN), Italy, 33081
        • Pfizer Investigational Site
      • Cattolica (RN), Italy, 47841
        • Pfizer Investigational Site
      • Modena, Italy, 41100
        • Pfizer Investigational Site
      • Orbassano (TO), Italy, 10043
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Rimini, Italy, 47900
        • Pfizer Investigational Site
      • Roma, Italy, 00157
        • Pfizer Investigational Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 410-769
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
  • Latvia
      • Riga, Latvia, LV 1002
        • Pfizer Investigational Site
      • Riga, Latvia, LV 1079
        • Pfizer Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Pfizer Investigational Site
      • Gdansk, Poland, 80-952
        • Pfizer Investigational Site
      • Krakow, Poland, 31-108
        • Pfizer Investigational Site
      • Krakow, Poland, 31-215
        • Pfizer Investigational Site
      • Lublin, Poland, 20-954
        • Pfizer Investigational Site
      • Olsztyn, Poland, 10-357
        • Pfizer Investigational Site
      • Olsztyn, Poland, 10-513
        • Pfizer Investigational Site
      • Rybnik, Poland, 44-200
        • Pfizer Investigational Site
      • Wodzislaw Sl., Poland, 44-300
        • Pfizer Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Pfizer Investigational Site
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Pfizer Investigational Site
      • Iasi, Romania, 700106
        • Pfizer Investigational Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Pfizer Investigational Site
  • Russian Federation
      • Krasnodar, Russian Federation, 350040
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115478
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 143423
        • Pfizer Investigational Site
      • Sochi, Russian Federation, 354057
        • Pfizer Investigational Site
      • St-Petersburg, Russian Federation, 194044
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 198255
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
      • Sremska Kamenica, Serbia, 21204
        • Pfizer Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Pfizer Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7925
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Girona, Spain, 17007
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Madrid, Spain, 28033
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Sevilla, Spain, 41009
        • Pfizer Investigational Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Pfizer Investigational Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08097
        • Pfizer Investigational Site
      • Manresa, Barcelona, Spain, 08243
        • Pfizer Investigational Site
      • Sabadell, Barcelona, Spain, 08208
        • Pfizer Investigational Site
  • Switzerland
      • Basel, Switzerland, CH-4031
        • Pfizer Investigational Site
      • Basel, Switzerland, CH-4058
        • Pfizer Investigational Site
      • CH-4101 Bruderholz, Switzerland
        • Pfizer Investigational Site
      • Chur, Switzerland, 7000
        • Pfizer Investigational Site
      • Liestal, Switzerland, CH-4410
        • Pfizer Investigational Site
  • Taiwan
      • Taichung, Taiwan, 404
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taoyuan County, Taiwan, 333
        • Pfizer Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 83092
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61070
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 03115
        • Pfizer Investigational Site
      • Sumy, Ukraine, 40005
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Pfizer Investigational Site
      • London, United Kingdom, SW3 6JJ
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Pfizer Investigational Site
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • Lakeport, California, United States, 95453
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • Orange, California, United States, 92868-3298
        • Pfizer Investigational Site
      • Petaluma, California, United States, 94954
        • Pfizer Investigational Site
      • Santa Rosa, California, United States, 95403
        • Pfizer Investigational Site
      • Thousand Oaks, California, United States, 91360
        • Pfizer Investigational Site
      • Westlake Valley, California, United States, 91360
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80205
        • Pfizer Investigational Site
      • Lafayette, Colorado, United States, 80026
        • Pfizer Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Lake City, Florida, United States, 32024
        • Pfizer Investigational Site
      • Lake City, Florida, United States, 32055
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Pfizer Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
      • Conyers, Georgia, United States, 30094
        • Pfizer Investigational Site
      • Cumming, Georgia, United States, 30041
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Duluth, Georgia, United States, 30096
        • Pfizer Investigational Site
      • Lake Spivey, Georgia, United States, 30236
        • Pfizer Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Pfizer Investigational Site
      • Snellville, Georgia, United States, 30078
        • Pfizer Investigational Site
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Pfizer Investigational Site
      • Peoria, Illinois, United States, 61615
        • Pfizer Investigational Site
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46237
        • Pfizer Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52402
        • Pfizer Investigational Site
      • Waterloo, Iowa, United States, 50701
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Pfizer Investigational Site
    • Mississippi
      • New Albany, Mississippi, United States, 38652
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States, 59102
        • Pfizer Investigational Site
      • Butte, Montana, United States, 59701
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
      • Manchester, New Hampshire, United States, 03102
        • Pfizer Investigational Site
    • New York
      • Amherst, New York, United States, 14221
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10461
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10467
        • Pfizer Investigational Site
      • Buffalo, New York, United States, 14263
        • Pfizer Investigational Site
      • Lake Success, New York, United States, 11042
        • Pfizer Investigational Site
      • Manhasset, New York, United States, 11030
        • Pfizer Investigational Site
      • New Hyde Park, New York, United States, 11040
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43221
        • Pfizer Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73102
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73109
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74133
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0334
        • Pfizer Investigational Site
      • Charlottesville, Virginia, United States, 22908-0716
        • Pfizer Investigational Site
      • Gloucester, Virginia, United States, 23601
        • Pfizer Investigational Site
      • Glouster, Virginia, United States, 23061
        • Pfizer Investigational Site
      • Newport News, Virginia, United States, 23601
        • Pfizer Investigational Site
      • Williamsburg, Virginia, United States, 23185
        • Pfizer Investigational Site
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Pfizer Investigational Site
    • West Virginia
      • Wheeling, West Virginia, United States, 26003-6300
        • Pfizer Investigational Site
    • Wyoming
      • Cody, Wyoming, United States, 82414
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A

The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.

CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 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.
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.
Drug: Erlotinib
Erlotinib (one tablet of 150 mg/day PO).
Drug: 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.
Active Comparator: Arm B
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)
Drug: Erlotinib
Erlotinib (one tablet of 150 mg/day PO).
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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
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
Percentage of Participants With Objective Response
Time Frame: 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
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
Maximum Observed Plasma Concentration (Cmax) for Figitumumab
Time Frame: 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
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
Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab
Time Frame: 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
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
Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)
Time Frame: 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
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
Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)
Time Frame: Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)
Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)
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)
Time Frame: Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), 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)
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)
Time Frame: 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)
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)
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)
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4021018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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