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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

Last updated on March 24, 2020

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Study Location
Pfizer Investigational Site
Florence, Alabama, 35630 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Squamous Cell Carcinoma, Adenosquamous Carcinoma, Large Cell Carcinoma, 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

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

- 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.

NCT00596830
Pfizer
Terminated
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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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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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