Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 684 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 3 of 683 sitesv684
  2. Re-verified, no change to tracked fieldsv683
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2017 to Jan 2018
    • Site details revised at 3 of 683 sites
    v682
  4. Results first posted: Apr 26, 2017
    • Study completion date: Dec 2017
    • Secondary endpoints revised (3)
    • Primary endpoint revised
    v681
  5. Primary completion date: Mar 2013 to Feb 2015v680
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv679
  2. Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncologyv678 Show 7 more changesShow less
    • Enrollment target: estimated 2900 to confirmed 2334
    • Study sites: 685 to 683
    • Interventions: bevacizumab (Biological), cetuximab (Biological), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium (Drug)… to FOLFIRI (Drug), FOLFOX or (Drug), bevacizumab (Biological), cetuximab (Biological)
    • Eligibility criteria expanded, about 445 words
    • Secondary endpoints: 4 to 3
    • Collaborators: 2 to 4
    • Study description shortened, about 1 word
  3. Primary completion date: Jun 2008 to Mar 2013
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 671 to 685
    v677
  4. Study sites: 665 to 671v676
  5. Study sites: 663 to 665v675
  6. Study sites: 657 to 663v674
  7. Study sites: 720 to 657v673
  8. Study sites: 721 to 720v672
  9. Site details revised at 2 of 721 sitesv671
  10. Study sites: 720 to 721v670
  11. Study sites: 719 to 720v669
  12. Study sites: 720 to 719v668
  13. Study sites: 719 to 720v667
  14. Study sites: 715 to 719v666
  15. Study sites: 717 to 715v665
  16. Study sites: 716 to 717v664
  17. Study sites revised (716)v663
  18. Study sites: 714 to 716v662
  19. Study sites: 715 to 714v661
  20. Study sites: 714 to 715v660
  21. Study sites: 713 to 714v659
  22. Study sites: 715 to 713v658
  23. Study sites: 716 to 715v657
  24. Study sites: 718 to 716v656
  25. Study sites: 717 to 718v655
  26. Study sites: 715 to 717v654
  27. Study sites: 712 to 715v653
  28. Study sites: 710 to 712v652
  29. Study sites: 708 to 710v651
  30. Study sites: 704 to 708v650
  31. Study sites: 710 to 704v649
  32. Study sites: 718 to 710v648
  33. Study sites: 720 to 718v647
  34. Study sites revised (720)v646
  35. Study sites: 713 to 720v645
  36. Study sites: 710 to 713v644
  37. Study sites: 708 to 710v643
  38. Study sites: 707 to 708v642
  39. Study sites: 705 to 707v641
  40. Study sites revised (705)v640
  41. Study sites: 704 to 705v639
  42. Study sites: 703 to 704v638
  43. Study sites: 704 to 703v637
  44. Study sites: 703 to 704v636
  45. Study sites: 690 to 703v635
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.
Trial Details
NCT Number NCT00265850
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), SWOG Cancer Research Network, Bristol-Myers Squibb, Aptuit
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms
Enrollment 2,334 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov