A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

NCT00600821

Last updated date
Study Location
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma, Adenocarcinoma
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

- Advanced non squamous cell, lung cancer

- No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment

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


- Prior therapy for advanced lung cancer


- The need for blood-thinners


- Coughing up blood

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Non-Small-Cell Lung Carcinoma, AdenocarcinomaA Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
NCT00600821
  1. Baton Rouge, Louisiana
  2. Pittsfield, Massachusetts
  3. Columbus, Mississippi
  4. Corinth, Mississippi
  5. New Albany, Mississippi
  6. Oxford, Mississippi
  7. Southaven, Mississippi
  8. Tupelo, Mississippi
  9. Lincoln, Nebraska
  10. Cleveland, Ohio
  11. Bartlett, Tennessee
  12. Germantown, Tennessee
  13. Memphis, Tennessee
  14. Memphis, Tennessee
  15. Dallas, Texas
  16. Dallas, Texas
  17. Dallas, Texas
  18. Dallas, Texas
  19. Lubbock, Texas
  20. San Antonio, Texas
  21. San Antonio, Texas
  22. Wenatchee, Washington
  23. Praha 8,
  24. Tabor,
  25. Usti nad Labem,
  26. Caen Cedex 05,
  27. Paris Cedex 14,
  28. Pierre-Bénite,
  29. Bydgoszcz,
  30. Gdansk,
  31. Gdynia,
  32. Torun,
  33. Warszawa,
  34. Mataro, Barcelona
  35. Sabadell, Barcelona
  36. Alicante,
  37. Valencia,
  38. Southampton, Hampshire
  39. Dundee, Scotland
  40. Leeds, Yorkshire
  41. Dundee,
  42. London,
  43. London,
  44. Surrey,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
Official Title  ICMJE Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer
Brief Summary To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small-Cell Lung Carcinoma
  • Adenocarcinoma
Intervention  ICMJE
  • Drug: Bevacizumab
    Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.
    Other Name: Avastin
  • Drug: Carboplatin
    Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.
  • Drug: Paclitaxel
    Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
  • Drug: AG-013736 (axitinib)
    AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-
    Other Name: axitinib Taxol
Study Arms  ICMJE
  • Active Comparator: B
    Bevacizumab will be administered in combination with carboplatin and paclitaxel.
    Interventions:
    • Drug: Bevacizumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: A
    AG-013736 will be administered in combination with carboplatin and paclitaxel.
    Interventions:
    • Drug: AG-013736 (axitinib)
    • Drug: Carboplatin
    • Drug: Paclitaxel
Publications * Twelves C, Chmielowska E, Havel L, Popat S, Swieboda-Sadlej A, Sawrycki P, Bycott P, Ingrosso A, Kim S, Williams JA, Chen C, Olszanski AJ, de Besi P, Schiller JH. Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Ann Oncol. 2014 Jan;25(1):132-8. doi: 10.1093/annonc/mdt489.

*   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: January 30, 2012)
118
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2008)
108
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced non squamous cell, lung cancer
  • No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment

Exclusion Criteria:

  • Prior therapy for advanced lung cancer
  • The need for blood-thinners
  • Coughing up blood
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 Czech Republic,   France,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00600821
Other Study ID Numbers  ICMJE A4061030
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 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