Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer

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NCT00147537

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Study Location
Pfizer Investigational Site
Tucson, Arizona, 85719, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of advanced/metastatic lung cancer

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous treatment with chemotherapy


- Uncontrolled diabetes


- History/active cardiovascular disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer
Official Title  ICMJE A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer
Brief Summary

Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.

Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: CP-751,871

    Phase 2 Arm A:

    CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles

  • Drug: paclitaxel

    Phase 2 Arm A:

    Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

    Phase 2 Arm B:

    Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

  • Drug: carboplatin

    Phase 2 Arm A:

    Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

    Phase 2 Arm B:

    Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

  • Drug: CP-751,871
    Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)
  • Drug: paclitaxel
    Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)
  • Drug: carboplatin
    Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)
  • Drug: erlotinib
    Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)
Study Arms  ICMJE
  • Experimental: Phase 2 (Arms A & B)
    CP-751,871 + paclitaxel + carboplatin
    Interventions:
    • Drug: CP-751,871
    • Drug: paclitaxel
    • Drug: carboplatin
  • Experimental: Phase 1b
    1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin
    2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib
    Interventions:
    • Drug: CP-751,871
    • Drug: paclitaxel
    • Drug: carboplatin
    • Drug: erlotinib
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2011)		282
Original Enrollment  ICMJE
 (submitted: September 2, 2005)		180
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of advanced/metastatic lung cancer

Exclusion Criteria:

  • Previous treatment with chemotherapy
  • Uncontrolled diabetes
  • History/active cardiovascular disease
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 Canada,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147537
Other Study ID Numbers  ICMJE A4021002
Has Data Monitoring Committee No
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 CenterPfizer
PRS Account Pfizer
Verification Date October 2013

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