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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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).

Detailed Summary:

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.


Sponsor: Pfizer

Current Primary Outcome: 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.


Original Primary Outcome: Overall Survival [ Time Frame: 24 months ]

Current Secondary Outcome:

  • 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.
  • 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.
  • 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 ]
  • 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 ]
  • 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.
  • 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) ]
  • 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.
  • 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.
  • 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

    Original Secondary Outcome:

    • To test for the presence of Circulating Tumor Cells (CTCs) expressing the IGF IR [ Time Frame: 24 months ]
    • To assess the differences in health state utilities using the EQ-5D [ Time Frame: 24 months ]
    • Progression Free Survival (PFS) [ Time Frame: 16 months ]
    • To assess the safety and tolerability of multiple doses of CP 751,871 [ Time Frame: 24 months ]
    • To assess the efficacy of CP 751,871 in terms of ORR [ Time Frame: 16 months ]
    • To collect PK data of CP 751,871 for population PK meta-analysis [ Time Frame: 24 months ]
    • To monitor for the occurrence of anti drug antibody in response to CP 751,871 [ Time Frame: 24 months ]


    Information By: Pfizer

    Dates:
    Date Received: May 5, 2008
    Date Started: May 2008
    Date Completion:
    Last Updated: July 22, 2013
    Last Verified: July 2013