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

Brief Summary

Official Title: “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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2011

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • 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.`
  • Active Comparator: B
    • Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.

Outcome Measures for this Clinical Trial

Primary Measures

  • Overall Survival (OS)
    • Time Frame: Baseline until death, assessed monthly after end of treatment, up to 30 months
      Safety Issue?: No

Secondary Measures

  • 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.
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels
    • Time Frame: Cycles 1 and 4 (predose) and at end of treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00596830