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Trial record 1 of 1 for:    NCT00596830
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Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

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ClinicalTrials.gov Identifier: NCT00596830
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 17, 2008
Results First Posted : December 3, 2013
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 3, 2008
First Posted Date  ICMJE January 17, 2008
Results First Submitted Date  ICMJE September 25, 2013
Results First Posted Date  ICMJE December 3, 2013
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
Overall Survival (OS) [ Time Frame: Baseline until death, assessed monthly after end of treatment, up to 30 months ]
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2008)
Overall Survival (OS) [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
  • Progression-Free Survival (PFS) [ Time Frame: At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months. ]
    PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study 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 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).
  • Percentage of Participants With Objective Response (OR) [ Time Frame: At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months ]
    Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months ]
    EORTC QLQ-C30: included 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 used 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.
  • European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score [ Time Frame: Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months ]
    QLQ-LC13 consisted 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 comprised 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.
  • Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months ]
    EQ-5D: 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 ("confined to bed"). 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 of -0.594 to 1; higher score indicates a better health state.
  • Maximum Observed Plasma Concentration (Cmax) for Figitumumab [ Time Frame: Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose ]
  • Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab [ Time Frame: Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose ]
  • Number of Participants With Total Anti-drug Antibodies (ADA) [ Time Frame: Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose ]
    ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.
  • Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels [ Time Frame: Cycles 1 and 4 (predose) and at end of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2008)
  • Progression Free Survival (PFS) [ Time Frame: 2.5 years ]
  • Overall safety profile [ Time Frame: 3 years ]
  • Patient reported outcomes (PROs) [ Time Frame: 3 years ]
  • Pharmacokinetics of CP- 751,871 [ Time Frame: 3 years ]
  • Anti drug antibody occurrence [ Time Frame: 3 years ]
  • Change in serum IGF1 levels [ Time Frame: 3 years ]
  • Overall objective response rate (ORR) [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
Official Title  ICMJE Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
Brief Summary Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.
Detailed Description The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: CP-751,871 (Figitumumab)
    CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
  • Drug: Carboplatin
    Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
  • Drug: Paclitaxel
    Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
  • Drug: Carboplatin
    Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
  • Drug: Paclitaxel
    Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
Study Arms  ICMJE
  • Experimental: A
    Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
    Interventions:
    • Drug: CP-751,871 (Figitumumab)
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Active Comparator: B
    Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
Publications * Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, Benner RJ, Scranton JR, Olszanski AJ, Jassem J. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2014 Jul 1;32(19):2059-66. doi: 10.1200/JCO.2013.54.4932. Epub 2014 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 17, 2011)
681
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2008)
820
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
  • Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
  • No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
  • Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
  • ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

  • Patients with symptomatic central nervous system (CNS) metastases are not permitted.
  • Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
  • Patients with other active cancer types are not permitted.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT00596830
Other Study ID Numbers  ICMJE A4021016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP